35574 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

1See PHS Act, Title XXXIII § 3312(a)(5). 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. CDC–2012–0007; NIOSH–257] 

42 CFR Part 88 

RIN 0920–AA49 

World Trade Center Health Program; 

Addition of Certain Types of Cancer to 

the List of WTC-Related Health 

Conditions 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: Title I of the James Zadroga 9/ 

11 Health and Compensation Act of 

2010 amended the Public Health Service 

Act (PHS Act) to establish the World 

Trade Center (WTC) Health Program. 

The WTC Health Program, which is 

administered by the Director of the 

National Institute for Occupational 

Safety and Health (NIOSH), within the 

Centers for Disease Control and 

Prevention (CDC), provides medical 

monitoring and treatment to eligible 

firefighters and related personnel, law 

enforcement officers, and rescue, 

recovery, and cleanup workers who 

responded to the September 11, 2001, 

terrorist attacks in New York City, at the 

Pentagon, and in Shanksville, 

Pennsylvania, and to eligible survivors 

of the New York City attacks. In 

accordance with our regulations, which 

establish procedures for adding a new 

condition to the list of health conditions 

covered by the WTC Health Program, 

this proposed rule would add certain 

types of cancer to the List of WTCRelated Health Conditions. 

DATES: Comments must be received by 

July 13, 2012. 

ADDRESSES: Written Comments: You 

may submit comments by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

• Facsimile: (513) 533–8285. 

Instructions: All submissions received 

must include the agency name (Centers 

for Disease Control and Prevention, 

HHS) and docket number (CDC–2012– 

007; NIOSH–257) or Regulation 

Identifier Number (0920–AA49) for this 

rulemaking. All relevant comments, 

including any personal information 

provided, will be posted without change 

to http://www.regulations.gov. For 

detailed instructions on submitting 

public comments, see the ‘‘Public 

Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents, go to 

http://www.regulations.gov or http:// 

www.cdc.gov/niosh/docket/archive/ 

docket257.html. 

FOR FURTHER INFORMATION CONTACT: 

Frank J. Hearl, PE, Chief of Staff, 

National Institute for Occupational 

Safety and Health, Centers for Disease 

Control and Prevention, Patriots Plaza, 

Suite 9200, 395 E St. SW., Washington, 

DC 20201. Telephone: (202) 245–0625 

(this is not a toll-free number). Email: 

WTCpublicinput@cdc.gov. 

SUPPLEMENTARY INFORMATION: This 

notice of proposed rulemaking is 

organized as follows: 

I. Executive Summary 

A. Purpose of Regulatory Action 

B. Summary of Major Provisions 

C. Costs and Benefits 

II. Public Participation 

III. Background 

A. WTC Health Program Statutory 

Authority 

B. Addition of Health Conditions to the 

List of WTC-Related Health Conditions 

C. Need for Rulemaking 

D. Addition of Certain Types of Cancer to 

the List of WTC-Related Health 

Conditions 

1. Scientific/Technical Advisory 

Committee (STAC) Recommendations 

2. Administrator’s Review of Available 

Scientific Information and the STAC’s 

Recommendations 

3. Methods Used by the Administrator to 

Determine Whether to Add Cancer or 

Types of Cancer to the List of WTCRelated Health Conditions 

4. Administrator’s Determination 

Concerning Petition 001 

5. Explanations for Adding Certain Types 

of Cancer to the List of WTC-Related 

Health Conditions 

6. Certification and Treatment of WTCRelated Health Conditions Including 

Types of Cancer 

7. Endnotes 

E. Effects of Rulemaking on Federal 

Agencies 

IV. Summary of Proposed Rule 

V. Regulatory Assessment Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children from Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

VI. Proposed Rule 

I. Executive Summary 

A. Purpose of Regulatory Action 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347), amended the Public 

Health Service Act (PHS Act) 

establishing the World Trade Center 

(WTC) Health Program within the 

Department of Health and Human 

Services (HHS). The PHS Act requires 

the WTC Program Administrator 

(Administrator) to conduct rulemaking 

to propose the addition of a health 

condition to the List of WTC-Related 

Health Conditions (List) codified in 42 

CFR 88.1 whether the Administrator 

adds a health condition based on the 

findings from periodic reviews of 

cancer,1 based on a request from a 

petition, or based on a determination 

made at the Administrator’s discretion 

that a proposed rule adding a condition 

should be initiated. Following a petition 

to add cancer or certain types of cancer 

to the List and a recommendation by the 

WTC Health Program’s Scientific/ 

Technical Advisory Committee (STAC), 

the Administrator is following the 

procedures established in 42 CFR 88.17 

to add some, but not all types of cancer 

recommended by the petition. 

B. Summary of Major Provisions 

This rule modifies the List of WTCRelated Health Conditions in 42 CFR 

88.1 to add the following conditions 

(types of cancer identified by ICD–10 

code are specified in the discussion 

below): 

D Malignant neoplasms of the lip, 

tongue, salivary gland, floor of mouth, 

gum and other mouth, tonsil, 

oropharynx, hypopharynx, and other 

oral cavity and pharynx 

D Malignant neoplasm of the 

nasopharynx 

D Malignant neoplasms of the nose, 

nasal cavity, middle ear, and 

accessory sinuses 

D Malignant neoplasm of the larynx 

D Malignant neoplasm of the esophagus 

D Malignant neoplasm of the stomach 

D Malignant neoplasm of the colon and 

rectum 

D Malignant neoplasm of the liver and 

intrahepatic bile duct 

D Malignant neoplasms of the 

retroperitoneum and peritoneum, 

omentum, and mesentery 

D Malignant neoplasms of the trachea; 

bronchus and lung; heart, 

mediastinum and pleura; and other 

ill-defined sites in the respiratory 

system and intrathoracic organs 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35575 

D Mesothelioma 

D Malignant neoplasms of the soft 

tissues (sarcomas) 

D Malignant neoplasms of the skin 

(melanoma and non-melanoma), 

including scrotal cancer 

D Malignant neoplasm of the breast 

D Malignant neoplasm of the ovary 

D Malignant neoplasm of the urinary 

bladder 

D Malignant neoplasm of the kidney 

D Malignant neoplasms of renal pelvis, 

ureter and other urinary organs 

D Malignant neoplasms of the eye and 

orbit 

D Malignant neoplasm of the thyroid 

D Malignant neoplasms of the blood and 

lymphoid tissues (including, but not 

limited to, lymphoma, leukemia, and 

myeloma) 

D Childhood cancers 

D Rare cancers 

The Administrator developed a 

hierarchy of methods (detailed in 

section III.D of this preamble) for 

determining which cancers to propose 

for inclusion on the List of WTC-Related 

Health Conditions. HHS is seeking 

comments on the proposed methods in 

this rule. 

C. Costs and Benefits 

Annual costs, benefits, and transfers 

of this rule are listed in the table below. 

This analysis estimates the impact on 

WTC Health Program costs using the 

number of persons currently enrolled in 

the program as responders and survivors 

and assumes that the rate of cancer in 

the population will be equal to the U.S. 

population average rate. An alternative 

analysis considers the impact on costs if 

the Program enrolls additional persons 

up to the Program’s statutory limits, and 

that the expanded population 

experiences a 21 percent higher rate of 

cancer than the U.S. population average. 

The basis for these assumptions is 

explained in detail in the preamble of 

this rulemaking. 

Although we cannot quantify the 

benefits associated with the WTC Health 

Program, enrollees with cancer are 

expected to experience a higher quality 

of care than they would in the absence 

of the Program. Mortality and morbidity 

improvements for cancer patients 

expected to enroll in the WTC Health 

Program are anticipated because barriers 

may exist to access and delivery of 

quality health care services for cancer 

patients in the absence of the services 

provided by the WTC Health Program. 

HHS anticipates benefits to cancer 

patients treated through the WTC Health 

Program, who may otherwise not have 

access to health care services, to accrue 

in 2013. Starting in 2014, continued 

implementation of the Affordable Care 

Act will result in increased access to 

health insurance and improved health 

care services for the general responder 

and survivor population that currently 

is uninsured. 

ESTIMATED ANNUAL WTC HEALTH PROGRAM COSTS, BENEFITS, AND TRANSFERS, 55,000 RESPONDERS AND 5,000 SURVIVORS AT U.S. POPULATION CANCER RATE, AND 80,000 RESPONDERS AND 30,000 SURVIVORS AT U.S. POPULATION CANCER RATE + 21 PERCENT, 2013–2016, 2011$ 

Societal Costs for 2013, 2011$ Annualized Transfers for 2013–2016, 

2011$ 

Based on the 16.3 percent of general 

responders and survivors who are 

expected to be uninsured 

Discounted at 7 

percent 

Discounted at 3 

percent 

Cancer Rate Cancer Rate 

U.S. Average U.S. + 21% U.S. Average U.S. + 21% 

55,000 Responders ................................................................. $1,648,706 .............................. $10,172,308 ..............................

5,000 Survivors ........................................................................ 271,427 .............................. 1,572,907 ..............................

Colorectal and Breast Screening ............................................. 204,491 .............................. 713,321 ..............................

60,000 Total ...................................................................... 2,124,624 .............................. 12,458,535 ..............................

80,000 Responders ................................................................. .............................. $2,631,100 .............................. $19,912,464 

30,000 Survivors ...................................................................... .............................. 1,970,560 .............................. 12,124,118 

Colorectal and Breast Screening ............................................. .............................. 417,521 .............................. 1,271,478 

110,000 Total .................................................................... .............................. 5,019,182 .............................. 33,308,060 

Qualitative benefits: 

Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are expected to experience a higher 

quality of care than they would in the absence of the Program. Mortality and morbidity improvements for cancer patients expected to enroll in 

the WTC Health Program are anticipated because barriers may exist to access and delivery of quality health care services for cancer patients 

in the absence of the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through the WTC 

Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting in 2014, continued implementation 

of the Affordable Care Act will result in increased access to health insurance and improved health care services for the general responder 

and survivor population that currently is uninsured. 

II. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

opinions, recommendations, and data. 

Comments received, including 

attachments and other supporting 

materials, are part of the public record 

and subject to public disclosure. Do not 

include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. 

Comments are invited on any topic 

related to this proposed rule. The 

Administrator is seeking comments 

from the public on the following 

specific topics: 

1. The four methods proposed to 

evaluate evidence for the addition of 

types of cancer to the List of WTCRelated Health Conditions; 

2. Information or published studies 

about the type of welding that occurred 

in the New York City disaster area, at 

the Pentagon, or at Shanksville, 

Pennsylvania with regard to metal 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35576 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

2Title XXXIII of the Public Health Service Act is 

codified at 42 U.S.C. 300mm to 300mm–61. Those 

portions of the Zadroga Act found in Titles II and 

III of Public Law 111–347 do not pertain to the 

World Trade Center Health Program and are 

codified elsewhere. 

3NTP Report on Carcinogens (RoC). http:// 

ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBAFA60E922B18C2540. Accessed May 9, 2012. 

cutting not involving exposure to 

ultraviolet light and welding involving 

ultraviolet light exposure; and 

3. Information or published studies 

about work hours scheduling or 

shiftwork occurring in the New York 

City disaster area, at the Pentagon, or in 

Shanksville, Pennsylvania. 

Comments submitted electronically or 

by mail should be titled ‘‘Docket No. 

CDC–2012–0007; NIOSH–257,’’ 

addressed to the ‘‘NIOSH Docket 

Officer,’’ and should identify the 

author(s) and contact information (such 

as return address, email address, or 

phone number), in case clarification is 

needed. Electronic and written 

comments can be submitted to the 

addresses provided in the ADDRESSES

section, above. All communications 

received on or before the closing date 

for comments will be fully considered 

by the Administrator of the WTC Health 

Program. 

III. Background 

A. WTC Health Program Statutory 

Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347), amended the Public 

Health Service Act (PHS Act) to add 

Title XXXIII 2 establishing the World 

Trade Center (WTC) Health Program 

within the Department of Health and 

Human Services (HHS). The WTC 

Health Program provides medical 

monitoring and treatment benefits to 

eligible firefighters and related 

personnel, law enforcement officers, 

and rescue, recovery, and cleanup 

workers who responded to the 

September 11, 2001, terrorist attacks in 

New York City, at the Pentagon, and in 

Shanksville, Pennsylvania, and to 

eligible survivors of the New York City 

attacks. 

All references to the Administrator of 

the WTC Health Program 

(Administrator) in this notice mean the 

NIOSH Director or his or her designee. 

Title XXXIII, § 3312(a)(6) of the PHS Act 

requires the Administrator to conduct 

rulemaking to propose the addition of a 

health condition to the List of WTCRelated Health Conditions (List) 

codified in 42 CFR 88.1. 

B. Addition of Health Conditions to the 

List of WTC-Related Health Conditions 

Under 42 CFR 88.17, the 

Administrator has established a process 

by which health conditions may be 

considered for addition to the List of 

WTC-Related Health Conditions in 

§ 88.1. Pursuant to § 3312(a)(6) of Title 

XXXIII of the PHS Act, the 

Administrator is required to publish a 

notice of proposed rulemaking and 

allow interested parties to comment on 

the proposed rule. The proposed rule 

may be initiated by the Administrator 

whenever he or she determines that a 

proposed rule should be promulgated to 

add a health condition (e.g., when a 

review of WTC Health Program 

monitoring data reveals the prevalence 

of a condition not previously identified 

in Title XXXIII or by the Program), on 

the basis of the WTC Health Program’s 

periodic review of all available 

scientific and medical evidence of 

cancer or a certain type of cancer 

pursuant to § 3312(a)(5) of Title XXXIII, 

or in response to a petition submitted by 

an interested party. Upon receipt of a 

petition from an interested party to add 

a condition to the List of WTC-Related 

Health Conditions, the Administrator is 

authorized to request a recommendation 

of the WTC Health Program STAC; or 

publish a proposed rule to add such 

health condition; or publish the 

Administrator’s determination not to 

publish a proposed rule and the basis 

for that determination; or to publish a 

determination that insufficient evidence 

exists to take action. 

C. Need for Rulemaking 

On September 7, 2011, the 

Administrator of the WTC Health 

Program received a written petition to 

add a health condition to the List of 

WTC-Related Health Conditions 

(Petition 001). Petition 001 requested 

that the Administrator ‘‘consider adding 

coverage for cancer under the Zadroga 

Act’’ to the List in § 88.1. [Maloney, et 

al. 2011] 

On October 5, 2011, the Administrator 

formally exercised his option to request 

a recommendation from the STAC 

regarding the petition (PHS Act, Title 

XXXIII, § 3312(a)(6)(B)(i); 42 CFR 

88.17(a)(2)(i)). The Administrator 

requested that the STAC ‘‘review the 

available information on cancer 

outcomes associated with the exposures 

resulting from the September 11, 2001, 

terrorist attacks, and provide advice on 

whether to add cancer, or a certain type 

of cancer, to the List specified in the 

Zadroga Act.’’ [Howard 2011] The 

background to this rulemaking and a 

discussion of the STAC’s 

recommendation are provided below. 

D. Addition of Certain Types of Cancer 

to the List of WTC-Related Health 

Conditions 

To determine whether the scientific 

evidence is sufficient to support the 

addition of cancer or types of cancer to 

the List of WTC-Related Health 

Conditions, the Administrator 

considered data from five information 

sources: (1) Peer-reviewed studies 

published in the scientific literature, 

including environmental sampling data, 

epidemiologic studies on the 9/11 

exposed populations, and studies 

providing evidence of a causal 

relationship between a type of cancer 

and a condition already on the List of 

WTC-Related Health Conditions; (2) 

findings and recommendations solicited 

from the WTC Clinical Centers of 

Excellence and Data Centers, the WTC 

Health Registry at the New York City 

Department of Health and Mental 

Hygiene, and the New York State 

Department of Health; (3) information 

from the public solicited through a 

request for information published in the 

Federal Register on March 8, 2011 and 

March 29, 2011; (4) the findings of the 

National Toxicology Program (NTP) in 

the National Institute of Environmental 

Health Sciences, HHS, as well as the 

World Health Organization’s 

International Agency for Research on 

Cancer (IARC); and (5) findings from 

other sources of information relevant to 

9/11 exposures, including the expert 

judgment and personal experiences of 

STAC members, and comments from the 

public. 

NTP, an interagency program that 

evaluates agents of public health 

concern using toxicology and molecular 

biology, publishes the biennial Report 

on Carcinogens (RoC), which contains a 

list of human carcinogens, exposure 

information, and descriptions of Federal 

exposure limits.3 The RoC classifies 

agents in one of two ways: known to be 

a human carcinogen, and reasonably 

anticipated to be a human carcinogen; 

this classification is determined by an 

expert panel convened for each 

candidate substance and is based on an 

evaluation of the published, peerreviewed literature and reviews 

conducted by Federal agencies and 

IARC. Unlike IARC, NTP does not 

identify specific types of cancer that 

have sufficient evidence of 

carcinogenicity. 

IARC, which coordinates and 

conducts research on the causes of 

human cancer and the mechanisms of 

carcinogenesis, maintains a series of 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35577 

4WHO International Agency for Research on 

Cancer (IARC). http://monographs.iarc.fr/. 

Accessed May 8, 2012. 

5Several other agents were recommended by the 

STAC, verified in the published literature, and are 

also considered 9/11 agents. The agents identified 

at the Pentagon and in Shanksville, Pennsylvania 

were reviewed but no additional agents were 

identified. 

6Limitations of the Zeig-Owens study include: 

Limited information on specific exposures 

experienced by firefighters; short time for follow-up 

of cancer outcomes; speculation about the 

biological plausibility of chronic inflammation as a 

possible mediator between WTC-exposure and 

cancer outcomes; and potential unmeasured 

confounders. 

7The Administrator’s methodology does not 

incorporate the standard established in Title 

XXXIII, § 3312(a)(2) to determine whether an 

individual can be diagnosed with a WTC-related 

health condition—that individual standard requires 

a determination that the terrorist attacks ‘‘were 

substantially likely to be a significant factor in 

aggravating, contributing to, or causing the 

[individual’s] illness or health condition.’’ The 

WTC Health Program regulations at 42 CFR 88.1 

define the ‘‘List of WTC-related health conditions’’ 

differently than a ‘‘WTC-related health condition’’ 

[in an individual]. For more information on the 

topic of certification of an individual, see Section 

III.D.6. below. 

Monographs on the carcinogenic risks to 

humans caused by chemicals, complex 

mixtures, occupational exposures, 

physical agents, biological agents, and 

lifestyle factors. In the Monographs, 

carcinogens are categorized according to 

whether they provide sufficient 

evidence of carcinogenicity in humans 

for a certain type of cancer (Group 1); 

or limited evidence of carcinogenicity in 

humans, including agents probably 

carcinogenic to humans (Group 2A) and 

agents possibly carcinogenic to humans 

(Group 2B); whether they are not 

classifiable as to carcinogenicity in 

humans (Group 3); or whether there is 

evidence suggesting lack of 

carcinogenicity (Group 4).4 IARC 

convenes working groups of 

international experts to develop each 

Monograph based on reviews of 

epidemiological, animal, and 

mechanistic data ‘‘that have been 

published or accepted for publication in 

the openly available scientific 

literature,’’ although ‘‘[i]n certain 

instances, government agency reports 

that have undergone peer review and 

are widely available are considered.’’ 

[IARC 2006] 

In July 2011, the Administrator 

released the First Periodic Review of the 

Scientific and Medical Evidence Related 

to Cancer for the World Trade Center 

Health Program (First Periodic Review). 

[NIOSH 2011] As required by Title 

XXXIII, § 3312(a)(5)(A) of the PHS Act, 

the Administrator reviewed ‘‘all 

available scientific and medical 

evidence, including findings and 

recommendations of Clinical Centers of 

Excellence, published in peer-reviewed 

journals to determine if, based on such 

evidence, cancer or a certain type of 

cancer should be added to the 

applicable list of WTC-related health 

conditions.’’ As described in the First 

Periodic Review, environmental 

sampling identified 287 chemicals and 

chemical groups as present in the New 

York City disaster area (referred to 

herein as ‘‘9/11 agents’’ 5). [COPC 2003] 

Published exposure assessments 

reviewed by the Administrator in the 

First Periodic Review ‘‘suggest that 

responders and others in the nearby area 

were potentially exposed to one or more 

of the substances designated by IARC 

and NTP as known or reasonably 

anticipated human carcinogens, 

although generally not in excess of 

applicable occupational exposure 

limits.’’ [NIOSH 2011] 

At the time of publication, the First 

Periodic Review [NIOSH 2011] 

identified only one peer-reviewed 

article addressing the association of 

exposures arising from the September 

11, 2001, terrorist attacks and cancer in 

responders and survivors, and two 

publications that used models to 

estimate the risk of cancer among 

residents in Lower Manhattan. The 

Administrator used a ‘‘weight of the 

evidence’’ approach to evaluate data 

derived from information sources (1)– 

(3), discussed above, and reported that 

insufficient evidence existed at that 

time to propose the addition of cancer 

or certain types of cancer to the List of 

WTC-Related Health Conditions. 

In September 2011, an epidemiologic 

study was published in The Lancet. The 

study, by Rachel Zeig-Owens and 

colleagues, ‘‘identified a modest effect 

of WTC exposure for all cancers 

combined by comparing the ratios in the 

exposed group [of Fire Department of 

New York City firefighters] to those in 

the non-exposed group.’’ [Zeig-Owens, 

et al. 2011] This publication led to the 

submission of Petition 001. 

In the petition, which was received 

shortly after publication of the ZeigOwens study, the petitioners stated they 

‘‘read with great concern * * * the 

study conducted by the New York City 

Fire Department and published last 

week in The Lancet that indicated an 

elevated risk of melanoma, thyroid and 

prostate cancer, and non-Hodgkin 

lymphoma among firefighters who 

served at ground zero.’’ While they ‘‘feel 

strongly there must be a scientific basis 

for adding coverage for new conditions 

under the Zadroga Act,’’ petitioners 

state that ‘‘given the severity of the 

illnesses reported in The Lancet, we 

also want to make sure that this and 

other peer-reviewed studies linking 

cancers to the [September 11, 2001] 

attacks are evaluated as expeditiously as 

possible.’’ [Maloney, et al. 2011] 

Title XXXIII, § 3302(a)(1) establishes 

the STAC, and charges it to ‘‘review 

scientific and medical evidence and to 

make recommendations to the 

Administrator on additional WTC 

Program eligibility criteria and on 

additional WTC-related health 

conditions.’’ Accordingly, when asked 

by the Administrator to provide a 

recommendation on Petition 001, the 

STAC established evidentiary criteria 

and assessed the weight of the available 

scientific evidence provided by 

information sources (1), (4), and (5), 

described above. The STAC found 

support for including a number of types 

of cancer based in part on evidence of 

increased risk reported in Zeig-Owens.6

The STAC also included a number of 

types of cancer based on the 

professional judgment of STAC 

members with scientific expertise, on 

the personal experience of some of the 

STAC members who were themselves 

WTC responders or survivors, and on 

comments made by the public. 

Unlike the explicit language in Title 

XXXIII, § 3312(a)(5)(A) of the PHS Act, 

which prescribes the standard to be 

used in the periodic reviews of cancer, 

§ 3312(a)(6) does not specifically limit 

the type of sources upon which the 

Administrator may base his or her 

determination to propose the addition of 

cancer or types of cancer to the List of 

WTC-Related Health Conditions. In this 

action, the Administrator’s 

determination is based on the 

information sources used in the First 

Periodic Review, the NTP’s RoC, the 

IARC Monographs, and from all other 

scientific information provided by the 

STAC, including the Zeig-Owens study 

which has been added to the peerreviewed epidemiologic literature and is 

discussed below. 

As discussed extensively below, the 

Administrator has adopted a formal 

methodology to evaluate the available 

scientific evidence. The formal 

methodology follows on criteria used by 

the STAC in its recommendation and is 

presented below, in section III.D.3.7

Based upon the new methodology, the 

Administrator proposes to add the types 

of cancer identified in section III.D.4., 

below, to the List of WTC-Related 

Health Conditions. The Administrator 

seeks comment on the methods 

developed, and the application of those 

methods, to add cancer or a type of 

cancer to the List of WTC-Related 

Health Conditions. 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35578 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

8See IARC http://monographs.iarc.fr/ENG/ 

Monographs/PDFs/index.php. 

1. STAC Recommendations 

In response to the Administrator’s 

October 5, 2011 request, the STAC met 

on three occasions—November 9–10, 

2011, February 15–16, 2012, and March 

28, 2012—to deliberate and develop 

recommendations on Petition 001 for 

the Administrator’s consideration. The 

Administrator received the STAC 

recommendations on April 2, 2012. 

[STAC 2012] 

In its April 2, 2012 recommendation 

to the Administrator, the chair of the 

STAC wrote that the STAC had: 

[R]eviewed available information on cancer 

outcomes that may be associated with the 

exposures resulting from the September 11, 

2001, terrorist attacks, and believes that 

exposures resulting from the collapse of the 

buildings and high-temperature fires are 

likely to increase the probability of 

developing some or all cancers. This 

conclusion is based primarily on the 

presence of approximately 70 known and 

potential carcinogens in the smoke, dust, 

volatile and semi-volatile contaminants 

identified at the World Trade Center site. 

Fifteen of these substances are classified by 

the International Agency for Research on 

Cancer (IARC) as known to cause cancer in 

humans, and 37 are classified by the National 

Toxicology Program (NTP) as reasonably 

anticipated to cause cancer in humans; others 

are classified by IARC as probable and 

possible carcinogens. Many of these 

carcinogens are genotoxic and it is therefore 

assumed that any level of exposure carries 

some risk. [STAC 2012] 

In its recommendation, the STAC also 

noted that ‘‘exposure data are extremely 

limited.’’ The STAC summarized the 

state of exposure assessment relevant to 

the terrorist attacks in New York City: 

No data were collected in the first 4 days 

after the attacks [in New York City], when the 

highest levels of air contaminants occurred, 

and the variety of samples taken on or after 

September 16, 2001 are insufficient to 

provide quantitative estimates of exposure on 

an individual or area level. However, the 

committee considers that the high prevalence 

of acute symptoms and chronic conditions 

observed in large numbers of rescue, 

recovery, cleanup and restoration workers 

and survivors, as well as qualitative 

descriptions of exposure conditions in 

downtown Manhattan, represent highly 

credible evidence that significant toxic 

exposures occurred. Furthermore, the salient 

biological reaction that underlies many 

currently recognized WTC health 

conditions—persistent inflammation—is now 

believed to be an important mechanism 

underlying cancer through generating DNAreactive substances, increasing cell turnover, 

and releasing biologically active substances 

that promote tumor growth, invasion and 

metastasis. 

In its recommendation to the 

Administrator, the STAC wrote: 

The committee deliberated on whether to 

designate all cancers as WTC-related 

conditions or to list only cancers with the 

strongest evidence. Some members proposed 

to include all cancers based on the 

incomplete and limited epidemiological data 

available to identify specific cancers, and 

others argued for the alternative of listing 

specific cancers based on best available 

evidence. The committee agreed to proceed 

by generating a list of cancers potentially 

related to WTC exposures based on evidence 

from three sources. [STAC 2012] 

The STAC based its Petition 001 

recommendation regarding the addition 

of certain types of cancer on evidence 

from four sources: 

1. 9/11 agents (those known and potential 

carcinogens identified in the New York City 

disaster area) with limited or sufficient 

evidence of carcinogenicity in humans based 

on International Agency for Research on 

Cancer (IARC) Monographs on the Evaluation 

of Carcinogenic Risks to Humans 8; 

2. Cancers arising from regions of the 

respiratory and digestive tracts where 

inflammatory conditions, such as 

gastroesophageal reflux disease (GERD), have 

been documented; 

3. Cancers for which epidemiologic studies 

have found some evidence of increased risk 

in WTC responder and survivor populations; 

and 

4. Findings from other sources of 

information relevant to 9/11 exposures and 

the potential occurrence of cancer, including 

the expert judgment and personal 

experiences of STAC members, and 

comments from the public. 

Based on these four evidentiary 

sources, the STAC recommended to the 

Administrator that the following 14 

cancer groups, encompassing many 

types of cancer, be added to the List of 

WTC-Related Health Conditions in 42 

CFR 88.1: 

1. Malignant neoplasms of the respiratory 

system (including nose, nasal cavity and 

middle ear, larynx, lung and bronchus, 

pleura, trachea, mediastinum, and other 

respiratory organs); 

2. Certain cancers of the digestive system, 

including esophagus, stomach, colon and 

rectum, liver and intrahepatic bile duct, 

retroperitoneum, peritoneum, omentum, and 

mesentery; 

3. Cancers of the oral cavity and pharynx, 

including lip, tongue, salivary gland, floor of 

mouth, gum and other mouth, nasopharynx, 

tonsil, oropharynx, hypopharynx and other 

oral cavity, and pharynx; 

4. Soft tissue sarcomas; 

5. Melanoma and non-melanoma skin 

cancers, including scrotal cancer; 

6. Mesothelioma of the pleura and 

peritoneum; 

7. Cancer of the ovary; 

8. Cancers of the urinary tract, including 

urinary bladder, kidney and renal pelvis, 

ureter, and other urinary organs; 

9. Cancer of the eye and orbit; 

10. Thyroid cancer; 

11. Lymphoma, leukemia, and myeloma; 

12. Breast cancer; 

13. Childhood cancers (all cancers 

diagnosed in persons less than 20 years old); 

and 

14. Rare cancers. 

In its recommendation to the 

Administrator, the STAC also made four 

additional points. 

First, the STAC recommended that as 

new epidemiologic studies of 9/11- 

exposed populations become available, 

the studies’ findings ‘‘be reviewed and 

modifications made to the list as 

appropriate.’’ [STAC 2012] 

Second, the STAC recommended that 

the WTC Health Program provide 

funding and guidelines for medical 

screening and early detection of cancer 

and appropriate counseling. [STAC 

2012] 

Third, the STAC emphasized that 

although evidence of carcinogenicity of 

9/11 agents from animal studies or 

mechanistic studies exists, 

because there is limited concordance 

between specific cancer sites affected in 

humans and in animals, only those 

substances classified based on human data 

are informative regarding organ sites of 

carcinogenicity in humans. [STAC 2012] 

Fourth, the STAC noted: 

In addition to the evidence considered by 

the committee to identify potential WTCrelated cancers, arguments in favor of listing 

cancer as a WTC-related condition include 

the presence of multiple exposures and 

mixtures with the potential to act 

synergistically and to produce unexpected 

health effects; the major gaps in the data with 

respect to the range and levels of 

carcinogens, the potential for heterogeneous 

exposures and hot spots representing 

exceptionally high or unique exposures both 

on the WTC site and in surrounding 

communities, the potential for 

bioaccumulation of some of the compounds, 

limitations of testing for carcinogenicity of 

many of the 287 agents and chemical groups 

cited in the first NIOSH Periodic Review, and 

the large volume of toxic materials present in 

the WTC towers. [STAC 2012] 

Finally, the STAC stated that 

[A]lthough acknowledging some lack of 

certainty in the evidence for targeting 

specific organs or organ site groupings as 

WTC-related, the majority of the committee 

agreed that recommending the specified 

cancer sites and site groupings was based on 

a sound scientific rationale and the best 

evidence available to date. [STAC 2012] 

2. Administrator’s Review of Available 

Scientific Information and the STAC’s 

Recommendations 

The Administrator agrees with the 

STAC that individual exposure 

assessment information arising from the 

terrorist attacks is extremely limited and 

that its absence impairs definitive 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35579 

9Four Bradford Hill criteria were not considered 

because, while useful in considering all sources of 

information, as the NTP and IARC reviews do, they 

have limited value when considering only the 

cancer epidemiologic studies of the 9/11-exposed 

population. Analogy establishes that if one 

exposure causes cancer, then a similar exposure 

should cause a similar cancer. This criterion is most 

useful with a large body of evidence. Specificity is 

not useful since many cancers are caused by 

multiple exposures. Temporal relationship 

establishes that exposure always precedes the 

outcome. Experiment establishes that the condition 

can be altered (prevented or ameliorated) by an 

appropriate experimental regimen. 

scientific analysis of the relationship 

between exposures arising from the 

attacks and the occurrence of any 

specific type of cancer. Also absent at 

the present time are multiple 

epidemiologic studies of cancer in 

exposed responders and survivors 

which definitively support an 

association between 9/11 exposures and 

specific types of cancer that would meet 

generally well-accepted criteria 

indicating that the association is a 

causal one. 

As noted in the First Periodic Review: 

Drawing causal inferences about exposures 

resulting from the September 11, 2001, 

terrorist attacks and the observation of cancer 

cases in responders and survivors is 

especially challenging since cancer is not a 

rare disease. In the United States, the 

probability that a person will develop cancer 

during their lifetime is one in two for men 

and one in three for women [ACS 2010]. This 

‘background’ rate of cancer development 

would be expected in responders and 

survivors even if the September 11, 2001, 

terrorist attacks had never occurred. 

Determining, then, if the September 11, 2001, 

exposures are contributing to an additional 

burden of cancer in responders and survivors 

is a scientific challenge. [NIOSH 2011] 

Also noted in the First Periodic 

Review, an important framework used 

by epidemiologists to assess the causal 

nature of an observed association is the 

‘‘Bradford Hill criteria.’’ [Hill 1965] The 

criteria are not intended to be a rigorous 

checklist, although they are often 

viewed in that way. None of the nine 

Bradford Hill criteria are alone 

sufficient to establish causation; 

together they can provide a starting 

point in evaluating whether an observed 

association is indeed a causal one. Five 

of those criteria are used by the 

Administrator in this rulemaking to 

evaluate evidence of a causal 

relationship between 9/11 exposures 

and a type of cancer: Strength of the 

association reported in the study 

between exposure agents and the type of 

cancer; consistency of the findings 

across multiple studies of exposed 

populations; biological gradient or doseresponse relationship between 

exposures and the type of cancer; and 

plausibility and coherence of the 

findings with known facts about the 

biology of the type of cancer.9

Given the limitations of the current 

peer-reviewed scientific literature on 

cancer and 9/11 exposures, the 

Administrator agrees with the 

approaches the STAC used to 

recommend cancers for addition to the 

List of WTC-Related Health Conditions, 

but seeks additional information or 

published studies that are informative 

on the subject of adding certain types of 

cancer to the List of WTC-Related 

Health Conditions (Section III.D.5). 

First, the STAC approach 

recommended including types of cancer 

for which IARC has categorized known 

9/11 agents as having sufficient (Group 

1 carcinogens) or limited (Group 2A 

probable carcinogens and Group 2B 

possible carcinogens) evidence for 

human carcinogenicity. IARC describes 

the evidence for carcinogenicity in 

humans as sufficient when a causal 

relationship has been established 

between exposure to the agent and 

human cancer. That is, a positive 

relationship has been observed between 

the exposure and a type of cancer in 

studies in which chance, bias, and 

confounding could be ruled out with 

reasonable confidence. IARC describes 

the evidence as limited when a positive 

association has been observed between 

the exposure and the cancer, and the 

IARC working group considered a 

causal interpretation to be credible but 

could not rule out chance, bias, or 

confounding with reasonable 

confidence. The Administrator has 

made the judgment that an IARC 

determination that the epidemiologic 

evidence for a 9/11 agent is sufficient or 

limited for a type of cancer qualifies the 

type for inclusion in the List of WTCRelated Health Conditions. The 

Administrator has further determined 

that evidence of exposure to 9/11 agents 

at any of the three sites—the New York 

City disaster area, the Pentagon, or 

Shanksville, Pennsylvania—qualifies for 

proposing the inclusion of a cancer 

type. The Administrator has also 

determined that cancers at sites in close 

anatomical proximity to sites proposed 

for inclusion under Method 3 (described 

in III.D.3., below) may also be added 

since it is often difficult to distinguish 

the cancer’s anatomical origin especially 

when cancers from closely proximate 

sites are histopathologically 

indistinguishable. 

Second, the STAC drew attention to 

types of cancers which arise in regions 

of the respiratory and digestive tracts 

where inflammatory conditions have 

been documented, some of which are 

health conditions already on the List of 

WTC-Related Health Conditions, 

including WTC-related health 

conditions of the upper and lower 

airway, and gastroesophageal reflux 

disease (GERD). The STAC cited several 

peer-review scientific publications 

about current scientific thinking on the 

relationship between inflammation and 

cancer. 

The Administrator agrees that a type 

of cancer may be added to the List if 

there is well-established scientific 

support for a causal relationship 

between that cancer and a WTC-related 

health condition already on the List. For 

example, when a WTC-related health 

condition (e.g., GERD) has been 

determined to be causally associated by 

means of multiple epidemiologic 

studies with the development of a 

particular type of cancer (e.g., 

esophageal cancer), the cancer type can 

be added to the List of WTC-Related 

Health Conditions. 

Third, the STAC included types of 

cancer based on an epidemiologic 

cohort study that identified a modest 

effect of WTC exposure for all cancers 

combined in exposed FDNY firefighters. 

[Zeig-Owens, et al. 2011] The STAC 

reviewed the Zeig-Owens study, which 

reported a 32 percent increase in the 

incidence of cancer among 9/11- 

exposed firefighters compared with nonexposed firefighters (Standardized 

Incidence Ratio (SIR) 1.32; 95% 

Confidence Interval (CI) 1.07–1.62). 

After correcting for possible 

surveillance bias, the increase was 

reduced to 21 percent (SIR 1.21; 95% CI 

0.98–1.49). [Zeig-Owens, et al. 2011] 

The Administrator believes that it is 

plausible that the overall rate of cancer 

cases in FDNY firefighters may have 

increased following those firefighters’ 

exposures to 9/11 agents, but agrees 

with the authors of the Zeig-Owens 

study who noted there could be other 

explanations for the findings: 

We remain cautious in our interpretation of 

these findings because the time interval since 

9/11 is short for cancer outcomes, the 

recorded excess of cancers is not limited to 

specific sites, and the biological plausibility 

of chronic inflammation as a possible 

mediator between WTC-exposure and cancer 

outcomes remains speculative. [Zeig-Owens, 

et al. 2011] 

The Administrator notes that the 

STAC recommended inclusion of five 

site-specific cancer types based on 

findings in the Zeig-Owens study when 

the incidence of certain types of cancer 

in exposed firefighters was compared to 

non-exposed firefighters. These cancers 

are stomach, colon (excluding rectum), 

melanoma, non-Hodgkin lymphoma, 

and thyroid. The Zeig-Owens study is 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35580 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

the only published study of a 9/11- 

exposed population currently available 

for review and presents the risk 

estimates in multiple ways. The 

Administrator agrees with the authors of 

the Zeig-Owens study, who note that 

‘‘[s]ite-specific cancer SIR ratios 

(exposed versus non-exposed) were not 

significantly increased, although we 

noted a trend towards an increase in ten 

of 15 sites.’’ [Zeig-Owens, et al., 2011] 

The Administrator placed a different 

emphasis on an interpretation of the 

statistical significance of the findings 

than did the STAC, and considered only 

the cancer risk estimates that were 

corrected for surveillance bias and that 

utilized the more similar referent group, 

unexposed firefighters. The 

Administrator has made the judgment 

that only statistically significant 

findings will be used to support the 

proposed inclusion of a type of cancer 

using Method 1, however cancers can be 

added under Methods 2, 3, 4 (see 

III.D.3., below). At the same time, the 

Administrator understands the 

interpretation of the findings from the 

Zeig-Owens study about site-specific 

cancer rates used by the STAC to 

recommend that stomach, colon 

(excluding rectum), melanoma, nonHodgkin lymphoma, and thyroid be 

included on the List of WTC-Related 

Health Conditions. 

Fourth, the STAC also considered 

findings from sources of information 

relevant to 9/11 exposures (including 

the expert judgment and personal 

experiences of STAC members, and 

comments from the public) and the 

potential occurrence of cancer. 

The Administrator considered the 

approaches used in the First Periodic 

Review and also the approaches used by 

the STAC to evaluate the available 

scientific evidence. In order to 

determine whether to propose a type of 

cancer for inclusion on the List, the 

Administrator sought to develop a 

method that would assist with 

characterizing 9/11 exposures and the 

likelihood of developing cancer or a 

type of cancer. One approach 

considered was to rely exclusively on a 

weight of evidence evaluation of the 

epidemiologic literature. In this 

approach, accumulated evidence from 

four types of studies (i.e., cohort, cross 

sectional, case-control, and case series) 

would be evaluated to develop insight 

into historic exposures and the risk of 

developing cancer or a type of cancer. 

Utilization of this approach would be 

consistent with the approach described 

by the Administrator in the First 

Periodic Review of cancer, a portion of 

the methodology adopted by the STAC, 

and Method 1 described in section 

III.D.3., below. However, evaluation of 

the epidemiologic literature is limited 

by both the lack of exposure data 

available for the days immediately after 

the collapse of the WTC Towers and the 

insufficient time for differences in 

cancer incidence and mortality to be 

detected in 9/11-exposed populations. 

Additional approaches were adopted to 

compensate for both of these 

limitations. Method 2 recognizes that 

certain WTC-related health conditions 

may progress to cancer. Method 3 is a 

qualitative approach that uses 

concordance between two authoritative 

reviews of peer-reviewed literature 

(NTP and IARC) as a threshold to 

characterize the likelihood of 9/11 

agents to cause cancer in humans. 

Method 4 relies on the work of the 

STAC in providing a reasonable basis 

for adding a type of cancer in addition 

to those identified under Methods 1–3. 

3. Methods Used by the Administrator 

To Determine Whether To Add Cancer 

or Types of Cancer to the List of WTCRelated Health Conditions 

The Administrator developed the 

following hierarchy of methods for 

determining whether to add cancer or 

types of cancer to the List of WTCRelated Health Conditions in 42 CFR 

88.1. In determining whether to propose 

that a type of a cancer be included on 

the List, a review of the evidence must 

demonstrate fulfillment of at least one of 

the following four methods: 

D Method 1. Epidemiologic Studies of 

September 11, 2001 Exposed Populations. A 

type of cancer may be added to the List if 

published, peer-reviewed epidemiologic 

evidence supports a causal association 

between 9/11 exposures and the cancer type. 

The following criteria extrapolated from the 

Bradford Hill criteria will be used to evaluate 

the evidence of the exposure-cancer 

relationship: 

• strength of the association between a 9/ 

11 exposure and a health effect (including 

the magnitude of the effect and statistical 

significance); 

• consistency of the findings across 

multiple studies; 

• biological gradient, or dose-response 

relationships between 9/11 exposures and 

the cancer type; and 

• plausibility and coherence with known 

facts about the biology of the cancer type. If 

only a single published epidemiologic study 

is available for review, the consistency of 

findings cannot be evaluated and strength of 

association will necessarily place greater 

emphasis on statistical significance than on 

the magnitude of the effect. 

D Method 2. Established Causal 

Associations. A type of cancer may be added 

to the List if there is well-established 

scientific support published in multiple 

epidemiologic studies for a causal association 

between that cancer and a condition already 

on the List of WTC-Related Health 

Conditions. 

D Method 3. Review of Evaluations of 

Carcinogenicity in Humans. A type of cancer 

may be added to the List only if both of the 

following criteria for Method 3 are satisfied: 

3A. Published Exposure Assessment 

Information. 9/11 agents were reported in a 

published, peer-reviewed exposure 

assessment study of responders or survivors 

who were present in either the New York 

City disaster area as defined in 42 CFR 88.1, 

or at the Pentagon, or in Shanksville, 

Pennsylvania; and 

3B. Evaluation of Carcinogenicity in 

Humans from Scientific Studies. NTP has 

determined that the 9/11 agent is known to 

be a human carcinogen or is reasonably 

anticipated to be a human carcinogen, and 

IARC has determined there is sufficient or 

limited evidence that the 9/11 agent causes 

a type of cancer. 

D Method 4. Review of Information 

Provided by the WTC Health Program 

Scientific/Technical Advisory Committee. A 

type of cancer may be added to the List if the 

STAC has provided a reasonable basis for 

adding a type of cancer and the basis for 

inclusion does not meet the criteria for 

Method 1, Method 2, or Method 3. 

The Administrator invites comment 

on this methodology and its 

implementation. The following 

schematic illustrates the methodology 

used in this rulemaking. 

BILLING CODE P 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35581 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.999</GPH>
35582 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

10Transcripts and recordings of the STAC 

meetings are available in NIOSH Docket 248 http:// 

www.cdc.gov/niosh/docket/archive/docket248.html. 

Accessed April 20, 2012. 

4. Administrator’s Determination 

Concerning Petition 001 

Using the evidentiary standards 

established above for inclusion of a 

cancer on the List of WTC-Related 

Health Conditions in 42 CFR 88.1, the 

Administrator reviewed the scientific 

evidence referenced in the First Periodic 

Review [NIOSH 2011], Petition 001, and 

in the STAC’s April 2, 2012 

recommendations to the 

Administrator.10 Accordingly, the 

Administrator proposes to add the 

specific types of cancers in Table A, 

below, to the List of WTC-Related 

Health Conditions in 42 CFR 88.1. 

BILLING CODE P 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35583 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.003</GPH>
35584 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.004</GPH>
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35585 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.005</GPH>
35586 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.006</GPH>
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35587 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.007</GPH>
35588 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.008</GPH>
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35589 

11The International Classification of Diseases 

(ICD) is used to code and classify injuries and 

diseases and their signs, symptoms, and external 

causes for statistical presentation, disease analysis, 

hospital records indexing, and medical billing 

reimbursement. 

5. Explanations for Adding Certain 

Types of Cancer to the List of WTCRelated Health Conditions 

The Administrator’s rationale and the 

method relied upon for inclusion of 

each type of cancer are offered below. 

The types of cancer proposed by the 

Administrator are grouped by 

anatomical region, for ease of 

discussion, and are identified by their 

individual ICD–10 code.11 [WHO 1997] 

The ICD–9 codes associated with each 

specific type of cancer are identified in 

the regulatory text. 

Cancers of the Head and Neck. For 

the reasons discussed below for each 

type, the Administrator proposes the 

inclusion of cancers found in the lip, 

tongue, salivary gland, floor of mouth, 

gum and other mouth, tonsil, 

oropharynx, nasopharynx, 

hypopharynx, other oral cavity and 

pharynx, nasal cavity, accessory 

sinuses, and the larynx. 

D Malignant neoplasms of the lip 

[C00], tongue [C01, C02], salivary gland 

[C07, C08], floor of mouth [C04], gum 

and other mouth [C03, C05, C06], tonsil 

[C09], oropharynx [C10], hypopharynx 

[C12, C13], other oral cavity and 

pharynx [C14]: (Method 3) IARC has 

determined that there is limited 

evidence that asbestos causes cancer of 

other oral cavity and pharynx. The 

review of published exposure 

assessment studies has not identified 

any 9/11 exposure agent associated with 

cancers of the lip, tongue, salivary 

gland, floor of mouth, gum and other 

mouth, tonsil, oropharynx, and 

hypopharynx. The Administrator has 

determined that the types of cancer 

proposed to be added in the Head and 

Neck group under Method 3 share an 

anatomic continuum and can be 

included with other head and neck 

group types of cancer. 

D Malignant neoplasm of the 

nasopharynx [C11]: (Method 3) The 

review of published exposure 

assessment studies identified 

formaldehyde as present in the New 

York City disaster area. [COPC 2003] 

IARC has determined that results of 

epidemiologic studies of exposure by 

inhalation to formaldehyde provide 

sufficient epidemiological evidence that 

formaldehyde causes nasopharyngeal 

cancer in humans. [IARC 2012c] 

D Malignant neoplasms of the nasal 

cavity [C30] and accessory sinuses 

[C31]: (Method 3) The review of 

published exposure assessment studies 

identified nickel and hexavalent 

chromium compounds as present in the 

New York City disaster area. [Lioy, et al. 

2002; COPC 2003; Lorber, et al. 2007] 

IARC has determined that results of 

epidemiologic studies of exposure by 

inhalation provide sufficient 

epidemiological evidence that nickel 

compounds cause cancer of the nose 

and nasal sinuses in humans. [IARC 

2012a] 

D Malignant neoplasm of the larynx 

[C32]: (Method 3) The review of 

published exposure assessment studies 

identified asbestos and sulfuric acid as 

present in the New York City disaster 

area. [Lioy, et al. 2002; COPC 2003; 

Lorber, et al. 2007] IARC has 

determined that results of epidemiologic 

studies of exposure by inhalation 

provide sufficient epidemiological 

evidence that all forms of asbestos 

(chrysotile, crocidolite, amosite, 

tremolite, actinolite, and anthophyllite) 

cause cancer of the larynx in humans. 

[IARC 2012a] IARC has determined that 

the results of epidemiologic studies of 

exposure by inhalation provide 

sufficient epidemiological evidence that 

strong inorganic acids including sulfuric 

acid cause cancer of the larynx. 

Cancers of the Digestive System. For 

the reasons discussed below for each 

site, the Administrator proposes the 

inclusion of cancers found in the 

esophagus; stomach; colon and rectum; 

liver and intrahepatic bile duct; 

retroperitoneum; and peritoneum. 

D Malignant neoplasms of the 

esophagus [C15]: (Method 2) There is 

well-accepted evidence that symptoms 

of an already-covered WTC-related 

health condition—gastroesophageal 

reflux disease (GERD)—increases the 

risk of developing esophageal cancer. 

Persons with recurring symptoms of 

reflux have an eightfold increase in the 

risk of esophageal adenocarcinoma. 

[Lagergren, et al., 1999] 

D Malignant neoplasm of the stomach 

[C16]: (Method 3) The review of 

published exposure studies identified 

asbestos and inorganic compounds of 

lead as present in the New York City 

disaster area. [COPC 2003] IARC has 

determined that the results of 

epidemiologic studies of exposure by 

inhalation and/or ingestion provide 

limited evidence that all forms of 

asbestos (chrysotile, crocidolite, 

amosite, tremolite, actinolite, and 

anthophyllite) cause cancer of the 

stomach in humans. [IARC 2012a] IARC 

has also determined that there is limited 

evidence that exposure to inorganic lead 

causes cancer of the stomach. [Cogliano, 

et al. 2011; IARC 2006] 

D Malignant neoplasms of the colon 

(and rectum) [C18, C19, C20, C26.0]: 

(Method 3) The review of published 

exposure assessment studies identified 

asbestos as present in the New York City 

disaster area. [COPC 2003] IARC has 

determined that the results of 

epidemiologic studies of exposure by 

inhalation provide limited 

epidemiologic evidence that all forms of 

asbestos (chrysotile, crocidolite, 

amosite, tremolite, actinolite, and 

anthophyllite) cause cancer of the colon 

and rectum in humans. [Cogliano, et al. 

2011] 

D Malignant neoplasms of the liver 

and intrahepatic bile duct [C22]: 

(Method 3) The review of published 

exposure assessment studies identified 

vinyl chloride, arsenic and inorganic 

arsenic compounds, polychlorinated 

biphenyls, and trichloroethylene as 

present in the New York City disaster 

area. [COPC 2003] Arsenic and vinyl 

chloride are classified as known human 

carcinogens by IARC and NTP. For 

arsenic, IARC identifies the evidence for 

causality of cancer of the liver and 

intrahepatic duct as limited and 

classifies the evidence for 

carcinogenicity of vinyl chloride as 

sufficient to cause angiosarcomas of the 

liver and hepatocellular carcinomas. For 

polychlorinated biphenyls and 

trichloroethylene exposure, IARC 

characterizes the evidence as limited for 

causation of cancer of the liver. 

[Cogliano, et al. 2011] 

D Malignant neoplasms of the 

retroperitoneum and peritoneum [C48]: 

The review of published exposure 

assessment studies has not associated 

any 9/11 agent with cancer of the 

retroperitoneum, peritoneum, omentum, 

and mesentery. The Administrator has 

determined that the types of cancer 

proposed to be added in the digestive 

system under Method 3 share an 

anatomic continuum and can be 

included together with other added 

digestive system types of cancer. 

Cancers of the Respiratory System. 

For the reasons discussed below for 

each site, the Administrator proposes 

the inclusion of cancers found in the 

trachea; bronchus and lung; heart; and 

other and ill-defined sites in the 

respiratory system and intrathoracic 

organs. 

D Malignant neoplasms of the trachea 

[C33]; bronchus and lung [C34]; heart, 

mediastinum and pleura [C38]; and 

other ill-defined sites in the respiratory 

system and intrathoracic organs [C39]: 

(Method 3) The review of published 

exposure assessment studies identified 

arsenic, asbestos, beryllium, cadmium, 

nickel, and silica as present in the New 

York City disaster area. [COPC 2003; 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35590 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

Lioy, et al. 2002; Wallingford and 

Snyder 2001] IARC has determined that 

there is sufficient evidence in humans 

for the carcinogenicity of mixed 

exposure to inorganic arsenic 

compounds, including arsenic trioxide, 

arsenite, and arsenate. Inorganic arsenic 

compounds, including arsenic trioxide, 

arsenite, and arsenate, cause cancer of 

the lung and intrathoracic organs. [IARC 

2012a] IARC has determined that there 

is sufficient evidence in humans that 

inhalation exposure to all forms of 

asbestos (chrysotile, crocidolite, 

amosite, tremolite, actinolite, and 

anthophyllite) causes cancer of the lung 

and intrathoracic organs (including C33, 

C34, C38, and C39). IARC has 

determined that results of epidemiologic 

studies of exposure by inhalation 

provide sufficient epidemiological 

evidence that beryllium and beryllium 

compounds cause cancer of the lung 

and intrathoracic organs. [IARC 2012a] 

IARC has determined that results of 

epidemiologic studies of exposure by 

inhalation provide sufficient 

epidemiologic evidence that cadmium 

and cadmium compounds cause cancer 

of the lung and intrathoracic organs in 

humans. [Cogliano, et al. 2011; IARC 

2012a] IARC has determined that results 

of epidemiologic studies of exposure by 

inhalation provide sufficient 

epidemiologic evidence that nickel 

compounds and nickel metal cause 

cancer of the lung and intrathoracic 

organs in humans. [Cogliano, et al. 

2011; IARC 2012a] IARC has determined 

that results of epidemiologic studies of 

exposure by inhalation provide 

sufficient epidemiologic evidence that 

crystalline silica in the form of quartz 

causes cancer of the lung and 

intrathoracic organs in humans. IARC 

has also determined that there is 

sufficient evidence in humans that soot 

causes cancer of the lung. [IARC 2012c] 

In addition, IARC has determined that 

strong inorganic acids, welding fumes, 

diesel exhaust and 2,3,7,8- 

tetrachlorodibenzo-para-dioxin have 

limited evidence for causing cancer of 

the respiratory system. 

Cancer of the Mesothelium. For the 

reasons discussed below, the 

Administrator proposes the inclusion of 

cancer found in the mesothelium. 

D Mesothelioma [C45]: (Method 3) 

The review of published exposure 

assessment studies identified asbestos 

as present in the New York City disaster 

area. [Lioy, et al. 2002; COPC 2003; 

Lorber, et al. 2007] IARC has 

determined that results of epidemiologic 

studies of exposure by inhalation 

provide sufficient epidemiologic 

evidence that all forms of asbestos 

(chrysotile, crocidolite, amosite, 

tremolite, actinolite, and anthophyllite) 

cause mesothelioma in humans. [IARC 

2012a] 

Cancer of the Soft Tissues. For the 

reasons discussed below, the 

Administrator proposes the inclusion of 

cancer found in the soft tissues. 

D Malignant neoplasm of peripheral 

nerves and autonomic nervous system 

[C47) and malignant neoplasm of other 

connective and soft tissue [C49]: 

(Method 3) The review of published 

exposure assessment studies identified 

2,3,7,8-tetrachlorodibenzo-para-dioxin 

as present in the New York City disaster 

area. [COPC 2003] IARC has found 

limited evidence for increased risk of 

soft tissue sarcoma associated with 

exposure to 2,3,7,8-tetrachlorodibenzopara-dioxin. 

Cancer of the Skin (non-melanoma 

and melanoma), including scrotum. For 

the reasons discussed below, the 

Administrator proposes the inclusion of 

cancer found in the skin. 

D Other malignant neoplasms of skin 

(non-melanoma) [C44], malignant 

melanoma of skin [C43], and malignant 

neoplasm of scrotum [C63.2]: (Method 3 

and 4) The review of published 

exposure assessment studies identified 

arsenic and soot as present in the New 

York City disaster area [COPC 2033). 

Both NTP and IARC determined that 

arsenic [IARC 2012c] and occupational 

exposure to soot [IARC 2012c] are 

known human carcinogens and that 

there is sufficient evidence that they 

cause non-melanoma skin cancer. 

The STAC recommended including 

melanoma based on its interpretation of 

the Zeig-Owens study. The STAC stated: 

the Zeig-Owens study found a statistically 

significant increase in melanoma among 

exposed firefighters compared to the general 

population; the Standardized Incidence Ratio 

(SIR) was slightly larger but not significant 

when compared to non-exposed firefighters. 

No adjustment for surveillance bias was 

reported for malignant melanoma, although 

early detection through medical surveillance 

is likely. 

Because the Zeig-Owens finding for 

melanoma was not statistically 

significant (when compared to nonexposed firefighters), the Administrator 

cannot propose to add melanoma to the 

List of WTC-Related Health Conditions 

based on Method 1. Melanoma is 

proposed for inclusion based on Method 

4. The Administrator will continue to 

monitor cohort studies that address sitespecific cancers such as melanoma in 9/ 

11-exposed populations. 

Cancer of the Breast. For the reasons 

discussed below, the Administrator 

proposes the inclusion of cancer found 

in the breast. 

D Malignant neoplasm of the breast 

[C50]: (Method 4) The STAC 

recommended inclusion of breast cancer 

based on the professional judgment and 

personal experience of STAC members 

and on public comments. The STAC 

stated 

There is evidence of PCB exposures to 

WTC responders and survivors based on air 

samples, window film samples and one 

biomonitoring study. Studies have linked 

total and congener-specific PCB levels in 

serum and adipose tissue with breast cancer, 

although evidence has been conflicting. PCBs 

and some other substances at the WTC site 

are endocrine disruptors. Breast cancer risks 

are highly related to hormonal factors, 

including endogenous and exogenous 

estrogens, and could plausibly be affected by 

endocrine disruptors. A recent study found 

that PCBs enhanced the metastatic properties 

of breast cancer cells by activating rhoassociated kinase. Shiftwork involving 

circadian rhythm disruption has been 

classified by IARC as probably carcinogenic 

to humans, based in part on epidemiologic 

studies associating shiftwork with increased 

risks of breast cancer. Both shiftwork and 

long shifts were common for workers 

involved in rescue, recovery, clean up, 

restoration and other activities at the WTC 

site. [STAC 2012, references omitted] 

The STAC further noted the lack of 

opportunity to find evidence for breast 

cancer among exposed occupations 

because so few women work in the 

occupations mainly involved with 

response work in the New York City 

disaster area, at the Pentagon, and in 

Shanksville, Pennsylvania. 

Shiftwork has been classified by IARC 

as probably carcinogenic based in part 

on limited evidence in humans 

demonstrating an increased risk of 

breast cancer among shift workers. IARC 

notes that mechanistic studies suggest 

that exposure to light at night may 

increase the risk of breast cancer by 

suppressing the normal nocturnal 

production of melatonin, which in turn, 

may alter gene expression in cancerrelated pathways. [Straif, et al. 2007] 

NTP has not yet examined the evidence 

for an association of shiftwork and 

breast cancer, however, NTP recently 

requested comment from the public 

whether shiftwork involving light at 

night should be nominated for possible 

review for future editions of the RoC. 

[NTP 2012] The Administrator is not 

aware of any published exposure 

assessment study of shiftwork and 9/11, 

although the Administrator is aware that 

extended work hours for many 

responders occurred at all three 9/11 

sites over several months. The 

Administrator proposes to add breast 

cancer to the List of WTC-Related 

Health Conditions based on Method 4, 

and continues to seek information about 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35591 

any exposures in the New York City 

disaster area, at the Pentagon, or in 

Shanksville, Pennsylvania that would 

further support adding breast cancer to 

the List of WTC-Related Health 

Conditions. 

Cancer of the Female Reproductive 

Organs. For the reasons discussed 

below, the Administrator proposes the 

inclusion of cancer found in the ovary. 

D Malignant neoplasm of the ovary 

[C56]: (Method 3) The review of 

published exposure assessment studies 

identified asbestos as present in the 

New York City disaster area. [Lioy, et al. 

2002; COPC 2003; Lorber, et al. 2007] 

IARC has determined that results of 

epidemiologic studies of exposure by 

inhalation provide sufficient 

epidemiological evidence that all forms 

of asbestos (chrysotile, crocidolite, 

amosite, tremolite, actinolite, and 

anthophyllite) cause cancer of the ovary 

in humans, based on five strongly 

positive cohort mortality studies of 

women with heavy occupational 

exposure to asbestos. [IARC 2012a] 

Cancers of the Urinary System. For 

the reasons discussed below, the 

Administrator proposes the inclusion of 

cancer found in the urinary bladder, 

kidney, renal pelvis, ureter and other 

urinary organs. 

D Malignant neoplasm of the urinary 

bladder [C67]: (Method 3) The review of 

published exposure assessment studies 

identified arsenic, inorganic arsenic, 

diesel exhaust and soot as present in the 

New York City disaster area. Both NTP 

and IARC determined that arsenic is 

known to be a human carcinogen [IARC 

2012a], and IARC has determined there 

is limited evidence that diesel engine 

exhaust and soot cause cancer of the 

urinary bladder. 

D Malignant neoplasm of the kidney 

[C64]: (Method 3) The review of 

published exposure assessment studies 

identified arsenic, inorganic arsenic 

compounds, and cadmium and 

cadmium compounds as present in the 

New York City disaster area. [COPC 

2003] The evidence for carcinogenicity 

of inorganic arsenic compounds and 

cadmium are categorized as limited by 

IARC and NTP, which meets the 

requirements for inclusion based on 

Method 3. 

D Malignant neoplasm of the renal 

pelvis, ureter and other urinary organs 

[C65, C66 and C68]: (Method 3) The 

Administrator has determined that the 

types of cancer proposed to be added in 

the urinary system under Method 3 

share an anatomic continuum and can 

be included together with other added 

urinary system types of cancer. 

Cancer of the Eye and Orbit. For the 

reasons discussed below, the 

Administrator proposes the inclusion of 

cancer found in the eye and orbit. 

D Malignant neoplasm of the eye and 

orbit [C69]: (Method 4) Cancers of the 

eye and eye orbit are not addressed in 

the only published epidemiologic study 

of September 11, 2001 exposed 

populations to date (Method 1). The 

STAC noted that eye irritation from dust 

was ubiquitous in the New York City 

disaster area and postulated an 

association between irritation from dust 

and cancers of the eye and eye orbit. 

However, irritation has not been 

associated with cancers of the eye and 

eye orbit in the published literature 

(Method 2). The STAC also noted that 

IARC determined the evidence is 

sufficient for welding to cause ocular 

melanoma by occupational exposure to 

ultraviolet radiation. The review of 

published exposure assessment studies 

identified metal cutting as occurring in 

the New York City disaster area, but the 

exposure assessment literature is silent 

about welding involving ultraviolet light 

exposure. The Administrator proposes 

to add cancer of the eye and orbit based 

on Method 4, but seeks information on 

welding activities in the New York City 

disaster area, at the Pentagon, or in 

Shanksville, Pennsylvania, including 

information on the types of welding, 

frequency, and locations to better 

understand the nature of the exposures 

that occurred that could further support 

adding cancer of the eye and orbit to the 

List of WTC-Related Health Conditions. 

Cancer of the Thyroid. For the reasons 

discussed below, the Administrator 

proposes the inclusion of cancer found 

in the thyroid. 

D Malignant neoplasm of thyroid 

gland [C73]: (Method 3) The STAC 

recommended thyroid cancer for 

inclusion, noting that it has not been 

associated with any of the agents known 

to be present in the New York City 

disaster area. The primary evidence that 

the STAC based its recommendation for 

inclusion on was ‘‘an excess in risk [for 

thyroid cancer] from the Zeig-Owens 

study.’’ [STAC 2012] Even though the 

Administrator views the significance of 

the Zeig-Owens finding relating to 

thyroid cancer differently than does the 

STAC, the Administrator proposes to 

add thyroid cancer to the List of WTCRelated Health Conditions based on 

Method 4. The Administrator will 

continue to monitor cohort studies that 

address site-specific cancer in 9/11- 

exposed populations. 

Cancers of the Blood and Lymphoid 

Tissue. For the reasons discussed below 

for each type, the Administrator 

proposes adding malignant neoplasms 

of the blood and lymphoid tissues, 

including, but not limited to, 

lymphoma, leukemia, and myeloma. 

D Hodgkin’s disease [C81]; follicular 

[nodular] non-Hodgkin lymphoma 

[C82]; diffuse non-Hodgkin lymphoma 

[C83]; peripheral and cutaneous T-cell 

lymphomas [C84]; other and 

unspecified types of non-Hodgkin 

lymphoma [C85]; malignant 

immunoproliferative diseases [C88]; 

multiple myeloma and malignant 

plasma cell neoplasms [C90]; lymphoid 

leukemia [C91]; myeloid leukemia 

[C92]; monocytic leukemia [C93]; other 

leukemias of specified cell type [C94]; 

leukemia of unspecified cell type [C95]; 

other and unspecified malignant 

neoplasms of lymphoid, hematopoietic 

and related tissue [C96]: (Method 3) The 

review of published exposure 

assessment studies identified benzene 

[Lorber, et al. 2007; Wallingford and 

Snyder 2001], 1,3-butadiene [Lorber, et 

al. 2007; Wallingford and Snyder 2001], 

and formaldehyde [COPC 2003] as 

present in the New York City disaster 

area. IARC determined that there is 

sufficient evidence that exposure to 1,3- 

butadiene causes cancer of the 

hematolymphatic organs. IARC 

considers hematolymphatic cancers 

attributable both to leukemia and 

malignant lymphoma. The IARC 

working group recognized that the 

epidemiological evidence for an 

association with specific subtypes of 

hematolymphatic cancers is weaker, but 

when malignant lymphomas and 

leukemias are distinguished, the 

evidence is strongest for leukemia. 

[IARC, 2012c] IARC also determined 

that there is sufficient evidence that 

exposure to benzene causes acute 

myeloid leukemia and acute nonlymphocytic leukemia. [Cogliano, et al. 

2011; IARC 2012c] IARC has determined 

that results of epidemiological studies of 

exposure by inhalation provide 

sufficient epidemiological evidence that 

formaldehyde causes leukemia in 

humans. [Cogliano, et al. 2011; IARC 

2012c] In addition, IARC has 

determined that there is limited 

evidence in humans that styrene, 

tetrachloroethylene, trichloroethylene, 

and 2,3,7,8-tetrachlorodibenzo-paradioxin cause leukemia. For the reasons 

discussed above, the Administrator 

intends to include all hematolymphatic 

cancers. 

Childhood Cancers. (Method 4) The 

STAC recommended that childhood 

cancers be included on the List of WTCRelated Health Conditions based on the 

‘‘unique vulnerability of children to 

synthetic chemicals’’ and that 

‘‘childhood cancers are rare and excess 

risks are not likely to be detectable in 

the small number of children being 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35592 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

12Rare Diseases Act of 2002 (Pub. L. 107–208), 

codified in Title IV, § 404f(c) of the PHS Act (42 

U.S.C. 283h(c)). 

13See § 3312(a)(1), Title XXXIII of the PHS Act; 

42 U.S.C. 300mm–22(a)(1). 

14The Department of Health and Human Services, 

in implementing the Affordable Care Act under the 

standard it sets out in revised § 2713(a)(5) of the 

Public Health Service Act, utilizes the 2002 

recommendation on breast cancer screening of the 

USPSTF. Available at http://www.

uspreventiveservicestaskforce.org/uspstf/uspsbrca

2002.htm. Accessed June 7, 2012. 

followed in epidemiologic studies.’’ 

[STAC 2012] The STAC defines 

childhood cancers as all cancers 

diagnosed in persons less than 20 years 

old. The most common types of 

childhood cancers are hematopoietic, 

bone, kidney, sarcomas, eye, and brain 

cancers. Childhood cancers involving 

the blood and lymphoid tissues, kidney, 

sarcomas, and eye cancers have already 

been added to the List and are described 

elsewhere in Section III.D.5. The 

Administrator proposes to add 

childhood cancers—any type of cancer 

occurring in a person less than 20 years 

of age—to the List of WTC-Related 

Health Conditions based on Method 4. 

The Administrator will continue to 

monitor cohort studies that address sitespecific cancer in 9/11-exposed 

populations of children less than 20 

years of age. 

Rare Cancers. (Method 4) The STAC 

recommended that rare cancers be 

included in the List of WTC-Related 

Health Conditions but noted that there 

is no uniform definition a rare cancer. 

The STAC also recommended that 

‘‘definitions be based on age-specific 

incidence rates by gender, decade of 

age, site and histology. Site/histology 

combinations to be considered as 

unique cancers should be determined a 

priori in consultation with appropriate 

experts.’’ The Rare Diseases Act of 2002 

defines a rare disease as one affecting 

‘‘small patient populations, typically 

populations smaller than 200,000 

individuals in the United States.’’ 12 The 

National Cancer Institute notes that 

‘‘there are some anatomic sites in which 

cancer rarely occurs.’’ [Young, et al. 

2007] For a limited population like that 

of the WTC Health Program, cancers 

that are considered rare based on 

occurrence rates in the U.S. population 

will be rare cancers for the 9/11-exposed 

populations. The Administrator 

proposes to add rare cancers—any type 

of cancer affecting populations smaller 

than 200,000 individuals in the United 

States, i.e., occurring at an incidence 

rate less than 0.08 percent of the U.S. 

population—to the List of WTC-Related 

Health Conditions based on Method 4 

and will consult with appropriate 

experts as recommended by the STAC. 

The Administrator also seeks 

information about rare cancers from the 

public. 

The Administrator will continue to 

review and evaluate the scientific 

evidence available to determine whether 

these types and any other types of 

cancer should be included in the List. 

These reviews will be published in the 

periodic reviews of cancer. Petitions to 

add types of cancer may also be filed 

with the Administrator. In the event 

additional studies are published prior to 

the issuance of a final rule regarding the 

subject of this notice of proposed 

rulemaking, the Administrator will 

consider those studies as appropriate in 

the process of developing a final rule. 

6. Certification and Treatment of WTCRelated Health Conditions Including 

Types of Cancer 

In order for an individual enrolled as 

a WTC responder or survivor to obtain 

coverage for treatment of any health 

condition on the List of WTC-Related 

Health Conditions, including any of 

type of cancer added to the List, a twostep process must be satisfied. First, a 

physician at a Clinical Center of 

Excellence or in the nationwide 

provider network must make a 

determination that the particular type of 

cancer for which the responder or 

survivor seeks treatment coverage is 

both: (1) On the List of WTC-Related 

Health Conditions; and that (2) exposure 

to airborne toxins, other hazards, or 

adverse conditions resulting from the 

September 11, 2001, terrorist attacks is 

substantially likely to be a significant 

factor in aggravating, contributing to, or 

causing the type of cancer for which the 

responder or survivor seeks treatment 

coverage.13 Pursuant to 42 CFR 88.12(a), 

the physician’s determination must be 

based on: (1) An assessment of the 

individual’s exposure to airborne toxins, 

any other hazard, or any other adverse 

condition resulting from the September 

11, 2001, attacks; and (2) the type of 

symptoms reported and the temporal 

sequence of those symptoms. As a 

second statutory requirement, all 

physician determinations are reviewed 

by the Administrator and, if found to 

satisfactorily meet the exposure 

assessment and symptom requirements, 

are certified for treatment coverage. 

Thus, inclusion of a condition on the 

List of WTC-Related Health Conditions, 

in and of itself, does not guarantee that 

a particular individual’s condition will 

be certified as eligible for treatment. 

Responders and survivors denied 

certification have a right to appeal the 

denial of certification. 

Early detection of cancer in 9/11- 

exposed populations—either as part of 

medical monitoring of enrolled WTC 

responders and survivors or part of 

ongoing research—is an important 

adjunct to the WTC Health Program. 

Screening for the cancers proposed by 

this rulemaking follow U.S. Preventive 

Services Task Force (USPSTF) 

Guidelines. There are two types of 

cancer proposed to be added to the List 

of WTC-Related Health Conditions for 

which the USPSTF has a current 

recommendation for screening. The 

USPSTF recommends screening for 

colorectal cancer (cancer of the colon 

and rectum) using fecal occult blood 

testing, sigmoidoscopy, or colonoscopy, 

in adults, beginning at age 50 years and 

continuing until age 75 years. [USPSTF 

2008] The Task Force also recommends 

breast cancer screening using biennial 

mammography for women beginning at 

age 40.14

7. Endnotes 

American Cancer Society [2012] Cancer Facts 

& Figures 2012. American Cancer Society, 

Atlanta, GA. Available at http://www.

cancer.org/Research/CancerFactsFigures/ 

CancerFactsFigures/cancer-facts-figures2012. 

Cogliano VJ, Baan R, Straif K, Grosse Y, 

Lauby-Secretan B, El Ghissassi F, Bouvard 

B, Benbrahim-Tallaa L, Guha N, Freeman 

C, Galichet L, Wild CP [2011]. Preventable 

Exposures Associated with Human 

Cancers. J Natl Cancer Inst 103:1827–1839. 

COPC (Contaminants of Potential Concern) 

Committee [2003]. World Trade Center 

Indoor Environment Assessment: Selecting 

Contaminants of Potential Concern and 

Setting Health-Based Benchmarks. http:// 

www.epa.gov/wtc/reports/ 

contaminants_of_concern_benchmark_

study.pdf. Accessed April 18, 2011. 

Bradford Hill A [1965]. The Environment and 

Disease: Association or Causation? 

Proceedings of the Royal Society of 

Medicine (May) 58:295–300. 

Howard J [2011]. October 5, 2011 Letter from 

John Howard, MD, Director, National 

Institute for Occupational Safety and 

Health (NIOSH) to the WTC Health 

Program Scientific/Technical Advisory 

Committee. This letter is included in the 

docket for this rulemaking. See 

http:www.regulations.gov and http:// 

www.cdc.gov/niosh/docket/archive/ 

docket257.html. 

IARC (International Agency for Research on 

Cancer) [1985]. IARC Monographs on the 

Evaluation of the Carcinogenic Risk of 

Chemicals to Humans: Vol. 35— 

Polynuclear Aromatic Compounds, Part 4, 

Bitumens, Coal-Tars and Derived Products, 

Shale-Oils and Soots. IARC, Lyon, France. 

http://monographs.iarc.fr/ENG/ 

Monographs/vol35/volume35.pdf. 

Accessed April 9, 2012. 

IARC (International Agency for Research on 

Cancer) [2006]. IARC Monographs on the 

Evaluation of the Carcinogenic Risk of 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35593 

15 28 CFR 104.21. 

Chemicals to Humans: Vol. 88— 

Formaldehyde, 2–Butoxyethanol and 1- 

tert-Butoxypropan-2-ol. IARC, Lyon, 

France. http://monographs.iarc.fr/ENG/ 

Monographs/vol88/index.php. Accessed 

April 9, 2012. 

IARC (International Agency for Research on 

Cancer) [2008]. IARC Monographs on the 

Evaluation of Carcinogenic Risks to 

Humans: Vol. 97—1,3–Butadiene, Ethylene 

Oxide and Vinyl Halides (Vinyl Fluoride, 

Vinyl Chloride and Vinyl Bromide). IARC, 

Lyon, France. http://monographs.iarc.fr/ 

ENG/Monographs/vol97/index.php. 

Accessed April 9, 2012. 

IARC (International Agency for Research on 

Cancer) [2012a]. IARC Monographs on the 

Evaluation of Carcinogenic Risks to 

Humans: Vol. 100—A Review of Human 

Carcinogens. Part C: Arsenic, Metals, 

Fibres, and Dusts. IARC, Lyon, France. 

http://monographs.iarc.fr/ENG/ 

Monographs/vol100C/index.php. Accessed 

April 9, 2012. 

IARC (International Agency for Research on 

Cancer) [2012b]. IARC Monographs on the 

Evaluation of Carcinogenic Risks to 

Humans: Vol. 100—A Review of Human 

Carcinogens. Part D: Radiation. IARC, 

Lyon, France. http://monographs.iarc.fr/ 

ENG/Monographs/vol100D/index.php. 

Accessed April 9, 2012. 

IARC (International Agency for Research on 

Cancer) [2012c]. IARC Monographs on the 

Evaluation of Carcinogenic Risks to 

Humans: Vol. 100—A Review of Human 

Carcinogens. Part F: Chemical Agents and 

Related Occupations. IARC, Lyon, France. 

http://monographs.iarc.fr/ENG/ 

Monographs/vol100F/index.php. Accessed 

April 9, 2012. 

Lagergren J, Bergstrom R, Lingren A, Nyren 

O [1999]. Symptomatic Gastroesophageal 

Reflux as a Risk Factor for Esophageal 

Adenocarcinoma. New Engl J Med 340(11): 

825–831. 

Lioy PJ, Weisel CP, Millette JR, Eisenreich S, 

Vallero D, Offenberg J, Buckley B, Turpin 

B, Zhong M, Cohen MD, Prophete C, Yang 

I, Stiles R, Chee G, et al. [2002]. 

Characterization of the Dust/Smoke 

Aerosol that Settled East of the World 

Trade Center (WTC) in Lower Manhattan 

after the Collapse of the WTC 11 

September 2001. Environ Health Perspect 

110(7):703–714. 

Lorber M, Gibb H, Grant L, Pinto J, Pleil J, 

Cleverly D [2007]. Assessment of 

Inhalation Exposures and Potential Health 

Risks to the General Population that 

Resulted from the Collapse of the World 

Trade Center Towers. Risk Anal 

27(5):1203–21. 

Maloney CB, Nadler J, King PT, Schumer CE, 

Gillibrand KE, Rangel CB, Velazquez NM, 

Grimm MG, Clarke YD. [2011]. Letter from 

Congress to John Howard, MD, Director, 

National Institute for Occupational Safety 

and Health (NIOSH). WTC Health Program 

Petition 001. Petition 001 is included in 

the docket for this rulemaking. See 

http:www.regulations.gov and http:// 

www.cdc.gov/niosh/docket/archive/ 

docket257.html. 

National Toxicology Program (NTP), 

Department of Health and Human 

Services. [2012] Request for Public 

Comment on Nominations and Call for 

Additional Nominations to the Report on 

Carcinogens. 77 Fed. Reg. 2728 (January 

12, 2012). 

NIOSH [2011]. First Periodic Review of 

Scientific and Medical Evidence Related to 

Cancer for the World Trade Center Health 

Program. NIOSH Publication No. 2011– 

197. http://www.cdc.gov/niosh/docs/2011– 

197/pdfs/2011–197.pdf/. Accessed April 

18, 2012. 

NTP (National Toxicology Program) [2011]. 

12th Report on Carcinogens. National 

Toxicology Program, Public Health Service, 

U.S. Department of Health and Human 

Services, Research Triangle Park, NC. 

http://ntp-server.niehs.nih.gov/ 

?objectid=72016262–BDB7–CEBA– 

FA60E922B18C2540. Accessed May 10, 

2012. 

Parekh P, Semkow T, Husain L, Wozniak G 

[2002]. Tritium in the World Trade Center 

September 11th, 2001 Terrorist Attack: Its 

possible sources and fate. Abstr Pap Am 

Chem Soc 223:026–NUCL. 

Pleil JD, Vette AF, Johnson BA, Rappaport 

SM [2004]. Air Levels of Carcinogenic 

Polycyclic Aromatic Hydrocarbons After 

the World Trade Center Disaster. Proc Natl 

Acad Sci USA. 101:11685–11688. 

Rare Diseases Act of 2002 (Pub. L. 107–208), 

codified in Title IV, § 404f(c) of the PHS 

Act (42 U.S.C. § 283h(c)). 

Young JL, Ward KC, Ries LAG, Chapter 30 in 

Ries LAG, Young JL, Keel GE, Eisner MP, 

Lin YD, Horner M–J (editors). SEER 

Survival Monograph: Cancer Survival 

Among Adults: U.S. Seer Program, 1988– 

2001, Patient and Tumor Characteristics. 

National Cancer Institute, SEER Program, 

NIH Pub. No. 07–6215, Bethesda, MD, 

2007. 

STAC (World Trade Center Health Program 

Scientific/Technical Advisory Committee) 

[2012]. Letter from Elizabeth Ward, Chair 

to John Howard, MD, Administrator. This 

letter is included in the docket for this 

rulemaking. See http:www.regulations.gov 

and http://www.cdc.gov/niosh/docket/ 

archive/docket257.html. 

Straif K, Baan R, Grosse Y, Secretan B, El 

Ghissassi F, Bouvard V, Altieri, 

Benbrahim-Tallaa L, Cogliano V [2007]. 

Carcinogenicity of Shift-Work, Painting, 

and Fire-Fighting. Lancet Oncol. Dec 

8:1065–1066. 

United States Preventive Services Task Force 

(USPSTF) [2008]. Screening for Colorectal 

Cancer. Available at http:// 

www.uspreventiveservicestaskforce.org/ 

uspstf/uspscolo.htm. Accessed May 28, 

2012. 

Wallingford KM, Snyder EM [2001]. 

Occupational Exposures During the World 

Trade Center Disaster Response. Toxicol 

Ind Health 17:247–253. 

WHO (World Health Organization) [1978]. 

International Classification of Diseases, 

Ninth Revision. Geneva: World Health 

Organization. 

WHO (World Health Organization) [1997]. 

International Classification of Diseases, 

Tenth Revision. Geneva: World Health 

Organization. 

Zeig-Owens R, Webber MP, Hall CB, 

Schwartz T, Jaber N, Weakley J, Rohan TE, 

Cohen HW, Derman O, Aldrich TK, Kelly 

K, Prezant DJ [2011]. Early Assessment of 

Cancer Outcomes in New York City 

Firefighters After the 9/11 Attacks: An 

Observational Cohort Study. Lancet. 

378(9794):898–905. 

E. Effects of Rulemaking on Federal 

Agencies 

Title II of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347) reactivated the 

September 11, 2001 Victim 

Compensation Fund (VCF). 

Administered by the U.S. Department of 

Justice (DOJ), the VCF provides 

compensation to any individual or 

representative of a deceased individual 

who was physically injured or killed as 

a result of the September 11, 2001, 

terrorist attacks or during the debris 

removal. Eligibility criteria for 

compensation by the VCF include a list 

of presumptively covered health 

conditions, which are physical injuries 

determined to be WTC-related health 

conditions by the WTC Health Program. 

Pursuant to DOJ regulations, the VCF 

Special Master is required to update the 

list of presumptively covered conditions 

when the List of WTC-Related Health 

Conditions in 42 CFR 88.1 is updated.15

IV. Summary of Proposed Rule 

The proposed rule would amend the 

definition of ‘‘List of WTC-Related 

Health Conditions’’ in 42 CFR 88.1, to 

include the types of cancer discussed 

above in section II.D. Table 1 in the 

regulatory text describes types of 

cancers included in 42 CFR 88.1 and 

identifies each by ICD–10 code. Because 

the ICD–10 modification will not be 

used by the U.S. healthcare system until 

October 1, 2014, the corresponding ICD– 

9 codes for the included cancer types 

are also provided in Table 1. 

The effect of this amendment would 

be that, for the types of cancers added, 

an enrolled WTC responder, certifiedeligible survivor, or screening-eligible 

survivor may seek certification of a 

physician’s determination that the 

September 11, 2001, terrorist attacks 

were substantially likely to be a 

significant factor in aggravating, 

contributing to, or causing the 

individual’s cancer. If the condition is 

certified by the Administrator, the 

individual may seek treatment and 

monitoring of this condition under the 

WTC Health Program. 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35594 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

16Based on a population of 60,000 at the U.S. 

cancer rate and discounted at 7 percent. 

17Based on a population of 110,000 at 21 percent 

above the U.S. cancer rate and discounted at 3 

percent. 

18PHS Act, Title XXXIII § 3311(a)(4)(A) and 

§ 3321(a)(3)(A). 19See 42 CFR 88.8(b) for explanation of a 

certified-eligible survivor. 20Zeig-Owens R, Webber MP, Hall CB, Schwartz 

T, Jaber N, Weakley J, Rohan TE, Cohen HW, 

Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. 

Early Assessment of Cancer Outcomes in New York 

City Firefighters After the 9/11 Attacks: An 

Observational Cohort Study. Lancet. 378(9794):898– 

905. 

21As Zeig-Owens et al point out, the time interval 

since 9/11 is short for cancer outcomes, the 

recorded excess of cancers is not limited to specific 

sites, and the biological plausibility of chronic 

inflammation as a possible mediator between WTCexposure and cancer means that the outcomes 

remain speculative. 

V. Regulatory Assessment 

Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. 

This rule has been determined to be 

a ‘‘significant regulatory action,’’ under 

§ 3(f) of E.O. 12866. The addition of 

specific types of cancer proposed to be 

added to the List of WTC-Related Health 

Conditions by this rule is estimated to 

cost the WTC Health Program between 

$2,124,624 16 and $5,019,182 17 (see 

Table 9) for the first year (2013). 

Because a portion of responders and 

survivors are also covered by private 

health insurance, employer-provided 

insurance (such as FDNY), or Medicare 

or Medicaid, only a portion of the costs, 

those costs representing the uninsured, 

are societal costs. All other costs to the 

WTC Health Program are transfers. After 

the implementation of provisions of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148) on January 1, 

2014, all of the costs to the WTC Health 

Program will be transfers. Transfers 

from FY 2013 through FY 2016 are 

expected to be between $12,458,535 and 

$33,308,060 per annum. Accordingly, 

this rule has been reviewed by the 

Office of Management and Budget. The 

proposed rule would not interfere with 

State, local, and Tribal governments in 

the exercise of their governmental 

functions. 

Cost Estimates 

The WTC Health Program has, to date, 

enrolled approximately 55,000 New 

York City responders and approximately 

5,000 survivors, or approximately 

60,000 individuals in total. Of that total 

population, approximately 59,000 

individuals were participants in 

previous WTC medical programs and 

were ‘grandfathered’ into the WTC 

Health Program established by Title 

XXXIII. These grandfathered members 

were enrolled without having to 

complete a new member application 

when the WTC Health Program started 

on July 1, 2011 and are referred to in the 

WTC Health Program regulations in 42 

CFR Part 88 as ‘‘currently identified 

responders’’ and ‘‘currently identified 

survivors.’’ In addition to those 

currently identified WTC responders 

and survivors already enrolled, the PHS 

Act 18 sets a numerical limitation on the 

number of eligible members who can 

enroll in the WTC Health Program 

beginning July 1, 2011 at 25,000 new 

WTC responders and 25,000 new 

certified-eligible WTC survivors 19 (i.e., 

the statute restricts new enrollment). 

Since July 1, 2011, a total of 

approximately 1,000 new WTC 

responders and new WTC survivors 

have enrolled in the WTC Health 

Program, resulting in only a minor 

impact on the statutory enrollment 

limits for new members. For the 

purpose of calculating a baseline 

estimate of cancer prevalence only, HHS 

assumed that this gradual rate of 

enrollment would continue, and that the 

currently enrolled population numbers 

would remain around 55,000 WTC 

responders and 5,000 WTC survivors. 

The estimate is further based on the 

average U.S. cancer prevalence rate, and 

7 percent discount rate. 

As it is not possible to identify an 

upper bound estimate, HHS has 

modeled another possible point on the 

continuum. For the purpose of 

calculating the impact of an increased 

rate of cancer on the WTC Health 

Program, this analysis assumes that the 

entire statutory cap for new WTC 

responders (25,000) and WTC survivors 

(25,000) will be filled. Accordingly, this 

estimate is based on a population of 

80,000 responders (55,000 currently 

identified + 25,000 new) and 30,000 

survivors (5,000 currently identified + 

25,000 new). The upper cost estimate 

also assumes an overall increase in 

population cancer rates of 21 percent 

due to 9/11 exposure,20 and costs were 

discounted at 3 percent. The choice of 

a 21 percent increase in the risk of 

cancer of the rate found in the unexposed population is based on findings 

presented in the only published 

epidemiologic study of September 11, 

2001 exposed populations to date. [ZeigOwens, et al. 2011] Given the challenges 

associated with interpreting the ZeigOwens findings,21 we simply 

characterize 21 percent as a possible 

outcome rather than asserting the 

probability that 21 percent is a ‘‘likely’’ 

outcome. HHS invites public comment 

on alternative approaches to estimating 

the costs and benefits described in this 

rulemaking, considering for example 

cancer latency. 

HHS acknowledges that some cancer 

cases are not likely to have been caused 

by exposure to 9/11 agents. The 

certification of individual cancer 

diagnoses will be conducted on a caseby-case basis, after consideration of the 

individual responder’s or survivor’s 

exposure to 9/11 agents and the 

temporal sequence of symptoms. 

However, for the purpose of this 

analysis, HHS has estimated that all 

diagnosed cancers proposed to be added 

to the List will be certified for treatment 

by the WTC Health Program. Finally, 

because there are no existing data on 

cancer rates related to exposure to 9/11 

agents at either the Pentagon or in 

Shanksville, Pennsylvania, HHS has 

used only data from studies of 

individuals who were responders or 

survivors in the New York City disaster 

area. HHS invites comment on this 

approach. 

Costs of Cancer Treatment 

HHS estimated the treatment costs 

associated with covering the select types 

of cancer proposed in this rulemaking 

using the methods described below. In 

the following discussion, the category of 

‘‘Head and Neck’’ includes all cancer 

cases from nasal cavity, nasopharynx, 

accessory sinuses, and larynx. The 

survival rates for all cancers in the 

‘‘Head and Neck’’ category were 

approximated using survival rates for 

cancer of the larynx. The category 

described as ‘‘Lung’’ in this discussion 

includes cancer of the trachea, bronchus 

and lung, heart, mediastinum and 

pleura, and other sites in the respiratory 

system and intrathoracic organs. 

Treatment costs for all respiratory 

system cancers including 

‘‘mesothelioma’’ were approximated by 

treatment costs for lung cancer. Costs of 

treatment for the ‘‘digestive system’’ 

were approximated using the costs of 

gastric cancer; costs for cancer of the 

‘‘skin’’ were approximated using costs 

for melanoma of the skin; ‘‘female 

reproductive organs’’ were 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35595 

22 Yabroff KR, Lamont EB, Mariotto A, Warren JL, 

Topor M, Meekins A, Brown ML [2008]. Cost of 

Care for Elderly Cancer Patients in the United 

States. Journal: J Natl Cancer Inst 100(9):630–41. 

23Surveillance, Epidemiology, and End Results 

(SEER) Program (www.seer.cancer.gov) Research 

Data (1973–2006), National Cancer Institute, 

DCCPS, Surveillance Research Program, 

Surveillance Systems Branch, released April 2009, 

based on the November 2008 submission. 

24Bureau of Labor Statistics. Consumer Price 

Index https://research.stlouisfed.org/fred2/series/ 

CPIMEDSL/downloaddata?cid=32419. Accessed 

April, 23, 2012. 

approximated using costs for cancer of 

the ovary; ‘‘urinary system’’ cancer was 

approximated by costs of urinary 

bladder cancer; and ‘‘blood and 

lymphoid tissue’’ cancers were 

approximated using leukemia and 

lymphoma. The costs for cancer 

identified with the ‘‘endocrine system,’’ 

the ‘‘soft tissue sarcomas,’’ and ‘‘eye/ 

orbit’’ were approximated using costs 

for treatment of ‘‘other’’ tumors. The 

‘‘other’’ category includes treatments 

costs from: salivary gland, nasopharynx, 

tonsil, small intestine, anus, 

intrahepatic bile duct, gallbladder, other 

biliary, retroperitoneum, peritoneum, 

other digestive organs, nose, nasal 

cavity, middle ear, larynx, pleura, 

trachea, mediastinum and other 

respiratory organs, bones and joints, soft 

tissue, other nonepithelial skin, vagina, 

vulva, other female genital organs, 

penis, other male genital organs, ureter, 

other urinary organs, eye and orbit, 

thyroid, other endocrine multiple 

myeloma, and miscellaneous. 

The WTC Health Program obtained 

data for the cost of providing medical 

treatment for each cancer type. The 

costs of treatment for each type of 

cancer are described in Table 1. The 

costs of treatment are divided into three 

phases: the costs for the first year 

following diagnosis, the costs of 

intervening years or continuing 

treatment after the first year, and the 

costs of treatment for the last year of 

life. The first year costs of cancer 

treatment are higher due to the initial 

need for aggressive medical (e.g. 

radiation, chemotherapy) and surgical 

care. The costs during last year of life 

are often dominated by increased 

hospitalization costs.22 Therefore, we 

used three different treatment phase 

costs to estimate the costs of treatment 

to be able to best estimate costs in 

conjunction with expected incidence 

and long-term survival for each type of 

cancer. 

TABLE 1—AVERAGE COSTS OF TREATMENT, MALE AND FEMALE

[2011 $] 

Category Initial 

(12 month) 

Continuing 

(annual) 

Last year of life 

(12 mos.) 

Head and Neck .......................................................................................................... $28,265 $3,136 $47,730 

Digestive System ....................................................................................................... 59,551 2,544 68,242 

Respiratory System ................................................................................................... 45,493 5,026 65,592 

Mesothelium ............................................................................................................... 45,493 5,026 65,592 

Skin ............................................................................................................................ 3,938 1,040 25,351 

Female Reproductive Organs .................................................................................... 66,527 5,023 64,728 

Urinary System .......................................................................................................... 16,926 3,630 40,905 

Blood & Lymphoid Tissue .......................................................................................... 33,312 5,782 69,070 

Endocrine System ...................................................................................................... 30,859 3,791 58,623 

Soft Tissue Sarcomas ............................................................................................... 30,859 3,791 58,623 

Melanoma .................................................................................................................. 3,938 1,040 25,351 

Breast ......................................................................................................................... 15,136 1,550 37,684 

Eye/Orbit .................................................................................................................... 30,859 3,791 58,623 

Source: Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, Meekins A, Brown ML [2008]. Cost of Care for Elderly Cancer Patients in 

the United States. Journal: J Natl Cancer Inst 100(9):630–41. 

These cost figures were based on a 

study of elderly cancer patients from 

Surveillance, Epidemiology, and End 

Results (SEER) program maintained by 

the National Cancer Institute, using 

Medicare files.23 The average costs of 

treatment described above are given in 

2011 prices adjusted using the Medical 

Consumer Price Index for all urban 

consumers.24

Incident Cases of Cancer 

HHS estimated the expected number 

of cases of cancer that would be 

observed in a cohort of responders and 

survivors followed for cancer incidence 

after September 11, 2001 using U.S. 

population cancer rates for the cancer 

types proposed to be added to the List 

of WTC-Related Health Conditions 

under this rulemaking. Demographic 

characteristics of the cohort were 

assigned since the actual data are not 

available for individuals in the 

responder and survivor populations 

who have not yet enrolled in the WTC 

Health Program. Gender and age (at the 

time of exposure) distributions for 

responders and survivors were assumed 

to be the same as current enrollees in 

the WTC Health Program. According to 

WTC Health Program data, males 

comprise 88 percent of the current 

responder enrollees and 50 percent of 

survivor enrollees. The age distribution 

for current enrollees by gender and 

responder/survivor status is presented 

in Table 2. 

TABLE 2—PERCENTILES OF CURRENT AGE (ON APRIL 11, 2012) FOR CURRENT ENROLLEES IN THE WTC HEALTH

PROGRAM BY GENDER AND RESPONDER/SURVIVOR STATUS

Age percentile (years) 

Group 

Min 1 10 30 50 70 90 99 Max 

Male responders .............................................................. 28 32 39 44 49 54 62 74 92 

Female responders .......................................................... 28 30 38 44 49 54 62 76 92 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35596 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

25 Jordan HT, Brackbill RM, Cone JE, 

Debchoudhury I, Farfel MR, Greene CM, Hadler JL, 

Kennedy J, Li J, Liff J, Stayner L, Stellman SD. 

Mortality Among Survivors of the Sept 11, 2001, 

Word Trade Center Disaster: Results from the World 

Trade Center Health Registry Cohort. Lancet 

2011;378:879–887. 

26Centers for Disease Control and Prevention, 

National Center for Health Statistics. Compressed 

Mortality File 1999–2008. CDC WONDER Online 

Database, compiled from Compressed Mortality File 

1999–2008 Series 20 No. 2N, 2011. Accessed at 

http://wonder.cdc.gov/cmf-icd10.html 15 February 

2012. 

27Schubauer-Berigan MK, Hein MJ, Raudabaugh 

WM, Ruder AM, Silver SR, Spaeth S, Steenland K, 

Petersen MR, and Waters KM [2011]. Update of the 

NIOSH Life Table Analysis System: A Person-Years 

Analysis program for the Windows Computing 

Environment. American Journal of Industrial 

Medicine 54:915–924. 

28National Cancer Institute, Surveillance 

Epidemiology and End Results (SEER). http:// 

seer.cancer.gov/. Accessed May 27, 2012. 

29National Cancer Institute, Surveillance 

Epidemiology and End Results (SEER). http:// 

seer.cancer.gov/. Accessed May 27, 2012. 

30The 15-year survival limit is imposed based on 

the analytic time horizon. 

31National Cancer Institute, Surveillance 

Epidemiology and End Results (SEER). http:// 

seer.cancer.gov/. Accessed May 27, 2012. 

TABLE 2—PERCENTILES OF CURRENT AGE (ON APRIL 11, 2012) FOR CURRENT ENROLLEES IN THE WTC HEALTH

PROGRAM BY GENDER AND RESPONDER/SURVIVOR STATUS—Continued 

Age percentile (years) 

Group 

Min 1 10 30 50 70 90 99 Max 

Male survivors .................................................................. 12 23 35 46 52 58 67 81 99 

Female survivors .............................................................. 12 21 38 49 54 60 68 84 95 

HHS assumed race and ethnic origin 

distributions for responders and 

survivors according to distributions in 

the WTC Health Registry cohort: 25 57 

percent non-Hispanic white, 15 percent 

non-Hispanic black, 21 percent 

Hispanic, and 8 percent other race/ 

ethnicity for responders and 50 percent 

non-Hispanic white, 17 percent nonHispanic black, 15 percent Hispanic, 

and 18 percent other race/ethnicity for 

survivors. Follow-up for cancer 

morbidity for each person began on 

January 1, 2002 or age 15 years, 

whichever was later. Age 15 was 

considered because the cancer 

incidence rate file did not include rates 

for persons less than 15 years of age. 

Follow-up ended on December 31, 2016 

or the estimated last year of life, 

whichever was earlier. The estimated 

last year of life was used since not all 

persons would be expected to remain 

alive at the end of 2016. The estimated 

last year of life was based on U.S. 

gender, race, age, and year-specific 

death rates from CDC Wonder (since 

rates are currently available through 

2008, the rate from 2008 was applied to 

2009 and later).26 A life-table analysis 

program, LTAS.NET, was used to 

estimate the expected number of 

incident cancers for cancer types 

proposed to be added.27 HHS calculated 

cancer incidence rates using data 

through 2006 from the Surveillance 

Epidemiology and End Results (SEER) 

Program, and estimated rates for 2007– 

2016.28 The Program applied the 

resulting gender, race, age, and yearspecific cancer incidence rates to the 

estimated person-years at risk to 

estimate the expected number of cancer 

cases for each cancer type starting from 

year 2002, the first full year following 

the September 11, 2001, terrorist 

attacks, to 2016, the last year for which 

this Program is authorized. 

Prevalence of Cancer 

To determine the potential number of 

persons in the responder and survivor 

populations with cancer, HHS used the 

number of incident cases described 

above for each year starting with 2002, 

and estimated the prevalence of cancer 

using survival rate statistics for each 

incident cancer group through 2016.29

Using the incident cases and survival 

rate statistics for each cancer type, HHS 

has estimated the prevalence (number of 

persons living with cancer) of cases 

during the 15 year period (2002–2016) 

since September 11, 2001. The resulting 

table provides for each year from 2002 

through 2016, the number of new cases 

occurring in that year (incidence), the 

number of individuals who died from 

their cancer in that year, and the 

number of persons surviving up to 15 

years beyond their first diagnosis with 

one table for each type of cancer 

(prevalence).30 For example, in 2002 

there are 23.47 projected new lung 

cancer cases, which would be listed as 

incident cases for that year. The survival 

rate for lung cancer in the first year of 

diagnosis is 40.6 percent.31 Therefore 

the number of deceased persons in 2002 

would be 18.78 × (1–0.406) = 11.15. For 

the lung cancer prevalence table, in year 

2003, the number of incident cases 

would be 20.88 cases. In addition to 

20.88 newly diagnosed cases in 2003, 

there would be the one-year survivors 

from 2002 which would be 18.78—11.15 

(or 18.78 × 0.406) = 7.62 cases. This 

computation process can be repeated for 

each year through year 2016. A portion 

of the lung cancer prevalence table is 

provided in Table 3 as an example. 

Prevalence tables were created for 

each type of covered cancer and the 

results are summarized in Tables 5, and 

7. This analysis considers cancers 

diagnosed in 2002 through 2016. 

TABLE 3—EXAMPLE FROM PREVALENCE TABLE FOR LUNG CANCER

[Based on 80,000 responders] 

Year 

Years since exposure to 9/11 agents Years covered by WTC Health Program 

2002 2003 2012 2013 2014 2015 2016 

1 (incidence) ............................................ 18.78 20.88 46.53 51.22 56.10 60.69 66.03 

2 ............................................................... .................... 7.62 17.00 18.89 20.79 22.78 24.64 

3 ............................................................... .................... .................... 9.25 10.18 11.30 12.45 13.63 

4 ............................................................... .................... .................... 6.42 7.08 7.79 8.66 9.53 

5 ............................................................... .................... .................... 4.95 5.46 6.02 6.62 7.35 

6 ............................................................... .................... .................... 4.01 4.45 4.90 5.40 5.94 

7 ............................................................... .................... .................... 3.28 3.67 4.07 4.49 4.94 

8 ............................................................... .................... .................... 2.71 3.03 3.38 3.76 4.14 

9 ............................................................... .................... .................... 2.55 2.49 2.78 3.10 3.45 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35597 

32Zeig-Owens R, Webber MP, Hall CB, Schwartz 

T, Jaber N, Weakley J, Rohan TE, Cohen HW, 

Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. 

Early Assessment of Cancer Outcomes in New York 

City Firefighters After the 9/11 Attacks: An 

Observational Cohort Study. Lancet. 378(9794):898– 

905. Limitations of the Zeig-Owens study include: 

limited information on specific exposures 

experienced by firefighters; short time for follow-up 

of cancer outcomes; speculation about the 

biological plausibility of chronic inflammation as a 

possible mediator between WTC-exposure and 

cancer outcomes; and potential unmeasured 

confounders. 

TABLE 3—EXAMPLE FROM PREVALENCE TABLE FOR LUNG CANCER—Continued 

[Based on 80,000 responders] 

Year 

Years since exposure to 9/11 agents Years covered by WTC Health Program 

2002 2003 2012 2013 2014 2015 2016 

10 ............................................................. .................... .................... 2.15 2.38 2.33 2.60 2.90

11 ............................................................. .................... .................... 1.78 1.98 2.20 2.14 2.40

12 ............................................................. .................... .................... .................... 1.66 1.84 2.04 1.99 

13 ............................................................. .................... .................... .................... .................... 1.52 1.69 1.88 

14 ............................................................. .................... .................... .................... .................... .................... 1.42 1.58 

15 ............................................................. .................... .................... .................... .................... .................... .................... 1.35 

Live cases from previous years ............... .................... .................... 54.11 61.26 68.94 77.16 85.74 

Prevalence ............................................... 18.78 28.50 100.64 112.48 125.03 137.85 151.78 

Last year of life ........................................ 11.15 15.46 39.38 43.54 47.87 52.10 56.79 

Cost Computation 

To compute the costs for each type of 

cancer, HHS assumes that all of the 

individuals who are diagnosed with a 

cancer type will be certified by the WTC 

Health Program for treatment and 

monitoring services. The treatment costs 

for the first year of treatment (Table 1, 

year adjusted) were applied to the 

predicted newly incident (Year 1) cases 

for each year. Likewise, the costs of 

treatment for the last year of life were 

applied in each year to the number of 

people predicted to die from their 

cancer in that year. The costs of 

continuing treatment from Table 1 were 

applied to the number of prevalent cases 

who had survived their cancers beyond 

their year of diagnosis, for each year of 

survival (Year 2–15). 

Using this procedure, a cost table is 

constructed for each year covered by the 

WTC Health Program. Table 4 provides 

an illustrative example for lung cancer. 

The row for Year 1 is the cost of 

incident cases for that year. Rows 2–15 

show the cost from continuing care for 

persons surviving n-years beyond the 

year of diagnosis. Finally, the cost of 

last year of life treatment is computed 

by multiplying the cost for last year of 

life from Table 1 by the number of 

persons dying in that year from that 

type of cancer. 

TABLE 4—COST PER 80,000 RESPONDERS FOR LUNG CANCER, 2011$ 

Year 

Years covered by the WTC Health Program 

2013 2014 2015 2016 

1 ............................................................................................... $914,986 $1,002,168 $1,084,205 $1,179,677 

2 ............................................................................................... 91,825 101,077 110,708 119,770 

3 ............................................................................................... 49,469 54,959 60,497 66,261 

4 ............................................................................................... 34,408 37,865 42,068 46,306 

5 ............................................................................................... 26,537 29,228 32,165 35,735 

6 ............................................................................................... 21,624 23,850 26,268 28,908 

7 ............................................................................................... 17,840 19,797 21,834 24,048 

8 ............................................................................................... 14,727 16,468 18,274 20,155 

9 ............................................................................................... 12,080 13,500 15,096 16,751 

10 ............................................................................................. 11,608 11,311 12,641 14,135 

11 ............................................................................................. 9,642 10,706 10,433 11,659 

12 ............................................................................................. 8,032 8,932 9,917 9,664 

13 ............................................................................................. .............................. 7,393 8,221 9,128 

14 ............................................................................................. .............................. .............................. 6,936 7,714 

15 ............................................................................................. .............................. .............................. .............................. 6,571 

Prevalent care .......................................................................... 1,212,778 1,337,254 1,459,263 1,589,911

Last year of life care ................................................................ 2,762,609 3,037,261 3,305,416 3,603,198 

Total .................................................................................. 3,975,387 4,374,515 4,764,679 5,193,109 

The sum of the annual costs for the 

years 2013 through 2016 represents the 

estimated treatment costs to the WTC 

Health Program for coverage of lung 

cancer for 80,000 responders. The cost 

projections in Table 4 are based on an 

assumed responder population size of 

80,000. 

The same process described above 

was applied to the survivor cohort. 

Based on the incidence rate expected 

from the survivor cohort, prevalence 

tables were constructed for each covered 

type of cancer. 

The estimated treatment costs for 

responders and survivors were recomputed under two assumptions: (1) 

Assuming the rate of cancer in the WTC 

Health Program is equal to the rate of 

cancer observed in the general 

population; and (2) assuming the rate of 

cancer exceeds the general population 

rate by 21 percent due to their 

exposures in the New York City disaster 

area.32 HHS is not aware of any other 

estimates of excess cancer rates in the 

9/11-exposed population in the peerreviewed literature. 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35598 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

A summary of the estimated 

prevalence at the U.S. population 

average for the assumed population of 

55,000 responders and 5,000 survivors 

is provided in Table 5. A summary of 

the estimated treatment costs to the 

WTC Health Program is provided in 

Table 6. 

A summary of the estimated 

prevalence using cancer rates 21 percent 

over the U.S. population average for the 

increased rate of 80,000 responders and 

30,000 survivors is given in Table 7. A 

summary of the estimated treatment 

costs to the WTC Health Program is 

provided in Table 8. 

TABLE 5—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE

Cancer type 

Prevalence (incident + live cases) 

2013 2014 2015 2016 

Based on 55,000 responder population 

Head & Neck ........................................................................... 89.41 99.20 109.35 119.83 

Digestive System ..................................................................... 136.54 150.69 165.19 180.38 

Respiratory System ................................................................. 77.91 86.61 95.50 105.16 

Mesothelioma ........................................................................... 1.02 1.12 1.23 1.35 

Skin .......................................................................................... 11.04 12.22 13.43 14.71 

Female Reproductive Organs .................................................. 5.14 5.64 6.14 6.65 

Urinary System ........................................................................ 108.78 121.39 134.69 148.90 

Blood & Lymphoid Tissue ........................................................ 119.72 130.72 141.97 153.71 

Endocrine System .................................................................... 53.50 58.75 64.05 69.40 

Soft Tissue Sarcomas ............................................................. 11.02 11.86 12.67 13.47 

Melanoma ................................................................................ 134.33 149.37 165.05 181.42 

Breast ....................................................................................... 102.30 113.46 124.91 136.66 

Eye/Orbit .................................................................................. 3.89 4.29 4.71 5.14 

Total .................................................................................. 854.59 945.32 1,038.88 1,136.78 

Based on 5,000 survivor population 

Head & Neck ........................................................................... 7.78 7.78 7.78 7.78 

Digestive System ..................................................................... 15.48 15.48 15.48 15.48 

Respiratory System ................................................................. 10.28 10.28 10.28 10.28 

Mesothelioma ........................................................................... 0.10 0.10 0.10 0.10 

Skin .......................................................................................... 1.13 1.13 1.13 1.13 

Female Reproductive Organs .................................................. 2.58 2.58 2.58 2.58 

Urinary System ........................................................................ 10.47 10.47 10.47 10.47 

Blood & Lymphoid Tissue ........................................................ 12.48 12.48 12.48 12.48 

Endocrine System .................................................................... 4.29 4.29 4.29 4.29 

Soft Tissue Sarcomas ............................................................. 0.96 0.96 0.96 0.96 

Melanoma ................................................................................ 12.21 13.58 15.00 16.49 

Breast ....................................................................................... 9.30 10.31 11.36 12.42 

Eye/Orbit .................................................................................. 0.35 0.39 0.43 0.47 

Total .................................................................................. 87.41 89.83 92.33 94.93 

TABLE 6—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE

[2011 $] 

Cancer type 2013 2014 2015 2016 2013–2016 

Based on 55,000 responder population 

Head & Neck ......................................... $925,673 $1,007,744 $1,089,966 $1,164,226 $4,187,609 

Digestive System ................................... 4,181,699 4,525,672 4,856,402 5,191,940 18,755,713 

Respiratory System ................................ 2,832,704 3,117,317 3,395,504 3,701,062 13,046,587 

Mesothelioma ......................................... 49,088 54,012 58,869 64,417 226,387 

Skin ........................................................ 18,078 20,075 21,834 23,072 83,059 

Female Reproductive Organs ................ 121,957 130,292 137,643 144,194 534,086 

Urinary System ...................................... 1,278,299 1,398,867 1,521,993 1,642,997 5,842,157 

Blood & Lymphoid Tissue ...................... 2,224,916 2,391,015 2,551,304 2,697,317 9,864,552 

Endocrine System .................................. 362,248 385,533 408,544 419,353 1,575,678 

Soft Tissue Sarcomas ............................ 148,358 158,024 167,208 175,680 649,270 

Melanoma .............................................. 229,538 249,805 270,744 284,528 1,034,615 

Breast ..................................................... 420,290 453,613 485,454 510,289 1,869,646 

Eye/Orbit ................................................ 36,018 39,242 42,470 45,255 162,985 

Total ................................................ 12,828,867 13,931,212 15,007,935 16,064,330 57,832,344 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35599 

TABLE 6—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE—Continued 

[2011 $] 

Cancer type 2013 2014 2015 2016 2013–2016 

Based on 5,000 survivor population 

Head & Neck ......................................... 77,325 82,580 87,736 92,044 339,685 

Digestive System ................................... 471,917 502,369 531,352 559,893 2,065,532 

Respiratory System ................................ 362,274 389,675 416,326 444,551 1,612,827 

Mesothelioma ......................................... 4,625 4,974 5,291 5,659 20,549 

Skin ........................................................ 1,843 2,034 2,196 2,300 8,372 

Female Reproductive Organs ................ 58,454 61,173 63,740 65,729 249,097 

Urinary System ...................................... 119,698 128,808 137,954 146,467 532,927 

Blood & Lymphoid Tissue ...................... 229,578 245,051 259,869 272,842 1,007,340 

Endocrine System .................................. 60,893 62,633 63,909 64,476 251,910 

Soft Tissue Sarcomas ............................ 14,017 14,748 15,415 15,960 60,140 

Melanoma .............................................. 30,943 32,541 33,962 35,142 132,588 

Breast ..................................................... 230,196 241,382 251,227 258,804 981,609 

Eye/Orbit ................................................ 3,434 3,642 3,832 3,994 14,903 

Total ................................................ 1,665,197 1,771,611 1,872,809 1,967,862 7,277,478 

Total 

Head & Neck ......................................... 1,002,998 1,090,324 1,177,702 1,256,270 4,527,294 

Digestive System ................................... 4,653,616 5,028,041 5,387,754 5,751,833 20,821,244 

Respiratory System ................................ 3,194,979 3,506,992 3,811,830 4,145,613 14,659,414 

Mesothelioma ......................................... 53,713 58,987 64,160 70,076 246,936 

Skin ........................................................ 19,921 22,109 24,030 25,371 91,431 

Female Reproductive Organs ................ 180,411 191,466 201,383 209,923 783,183 

Urinary System ...................................... 1,397,997 1,527,675 1,659,948 1,789,465 6,375,084 

Blood & Lymphoid Tissue ...................... 2,454,494 2,636,067 2,811,173 2,970,159 10,871,892 

Endocrine System .................................. 423,141 448,166 472,452 483,829 1,827,588 

Soft Tissue Sarcomas ............................ 162,376 172,772 182,622 191,640 709,410 

Melanoma .............................................. 260,481 282,346 304,706 319,670 1,167,203 

Breast ..................................................... 650,486 694,995 736,681 769,093 2,851,255 

Eye/Orbit ................................................ 39,452 42,885 46,302 49,250 177,888 

Total ................................................ 14,494,064 15,702,823 16,880,744 18,032,192 65,109,823 

TABLE 7—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE

Cancer type 

Prevalence (incident + live cases) 

2013 2014 2015 2016 

Based on 80,000 responder population 

Head & Neck ........................................................................... 157.36 174.59 192.45 210.91 

Digestive System ..................................................................... 240.31 265.21 290.74 317.47 

Respiratory System ................................................................. 137.12 152.43 168.07 185.08 

Mesothelioma ........................................................................... 1.79 1.98 2.16 2.38 

Skin .......................................................................................... 19.43 21.50 23.64 25.89 

Female Reproductive Organs .................................................. 9.05 9.92 10.81 11.71 

Urinary System ........................................................................ 191.45 213.66 237.05 262.06 

Blood & Lymphoid Tissue ........................................................ 210.70 230.07 249.86 270.52 

Endocrine System .................................................................... 94.16 103.40 112.73 122.15 

Soft Tissue Sarcomas ............................................................. 19.40 20.87 22.29 23.70 

Melanoma ................................................................................ 236.42 262.90 290.50 319.30 

Breast ....................................................................................... 180.05 199.69 219.84 240.52 

Eye/Orbit .................................................................................. 6.85 7.56 8.29 9.05 

Total .................................................................................. 1,504.09 1,663.77 1,828.43 2,000.74 

Based on 30,000 survivor population 

Head & Neck ........................................................................... 56.51 56.51 56.51 56.51 

Digestive System ..................................................................... 112.39 112.39 112.39 112.39 

Respiratory System ................................................................. 74.61 74.61 74.61 74.61 

Mesothelioma ........................................................................... 0.70 0.70 0.70 0.70 

Skin .......................................................................................... 8.21 8.21 8.21 8.21 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35600 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

TABLE 7—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE—Continued 

Cancer type 

Prevalence (incident + live cases) 

2013 2014 2015 2016 

Female Reproductive Organs .................................................. 18.73 18.73 18.73 18.73 

Urinary System ........................................................................ 76.04 76.04 76.04 76.04 

Blood & Lymphoid Tissue ........................................................ 90.61 90.61 90.61 90.61 

Endocrine System .................................................................... 31.11 31.11 31.11 31.11 

Soft Tissue Sarcomas ............................................................. 6.94 6.94 6.94 6.94 

Melanoma ................................................................................ 88.66 98.59 108.94 119.74 

Breast ....................................................................................... 67.52 74.88 82.44 90.20 

Eye/Orbit .................................................................................. 2.57 2.83 3.11 3.39 

Total .................................................................................. 634.60 652.16 670.34 689.18 

TABLE 8—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE

[2011 $] 

Cancer type 2013 2014 2015 2016 2013–2016 

Based on 80,000 responder population 

Head & Neck ......................................... $1,656,113 $1,802,945 $1,950,049 $2,082,906 $7,492,013 

Digestive System ................................... 7,481,440 8,096,839 8,688,544 9,288,852 33,555,675 

Respiratory System ................................ 5,067,965 5,577,164 6,074,865 6,621,536 23,341,531 

Mesothelioma ......................................... 87,823 96,633 105,323 115,248 405,027 

Skin ........................................................ 32,344 35,916 39,063 41,278 148,600 

Female Reproductive Organs ................ 218,192 233,104 246,256 257,976 955,528 

Urinary System ...................................... 2,286,993 2,502,701 2,722,984 2,939,472 10,452,150 

Blood & Lymphoid Tissue ...................... 3,980,577 4,277,744 4,564,514 4,825,745 17,648,581 

Endocrine System .................................. 648,095 689,754 730,922 750,261 2,819,031 

Soft Tissue Sarcomas ............................ 265,426 282,719 299,150 314,308 1,161,603 

Melanoma .............................................. 410,664 446,924 484,385 509,047 1,851,021 

Breast ..................................................... 751,937 811,554 868,522 912,953 3,344,966 

Eye/Orbit ................................................ 64,439 70,208 75,983 80,965 291,595 

Total ................................................ 22,952,009 24,924,205 26,850,560 28,740,547 44,654,652 

Based on 30,000 survivor population 

Head & Neck ......................................... 467,817 499,610 530,802 556,869 2,055,097 

Digestive System ................................... 2,855,098 3,039,331 3,214,682 3,387,354 12,496,466 

Respiratory System ................................ 2,191,761 2,357,535 2,518,774 2,689,533 9,757,602 

Mesothelioma ......................................... 27,979 30,096 32,010 34,239 124,324 

Skin ........................................................ 11,149 12,304 13,285 13,912 50,650 

Female Reproductive Organs ................ 353,646 370,100 385,629 397,662 1,507,036 

Urinary System ...................................... 724,172 779,285 834,625 886,127 3,224,209 

Blood & Lymphoid Tissue ...................... 1,388,944 1,482,561 1,572,207 1,650,695 6,094,408 

Endocrine System .................................. 368,403 378,927 386,647 390,079 1,524,055 

Soft Tissue Sarcomas ............................ 84,805 89,226 93,258 96,557 363,846 

Melanoma .............................................. 187,204 196,873 205,471 212,608 802,156 

Breast ..................................................... 1,392,687 1,460,361 1,519,924 1,565,763 5,938,735 

Eye/Orbit ................................................ 20,776 22,037 23,182 24,166 90,160 

Total ................................................ 4,912,377 5,256,038 5,588,087 5,914,152 21,670,654 

Total 

Head & Neck ......................................... 2,123,930 2,302,555 2,480,851 2,639,775 9,547,110 

Digestive System ................................... 10,336,538 11,136,171 11,903,227 12,676,206 46,052,141 

Respiratory System ................................ 7,259,726 7,934,699 8,593,639 9,311,069 33,099,133 

Mesothelioma ......................................... 115,803 126,729 137,333 149,487 529,350 

Skin ........................................................ 43,493 48,220 52,348 55,190 199,251 

Female Reproductive Organs ................ 571,838 603,204 631,884 655,638 2,462,564 

Urinary System ...................................... 3,011,165 3,281,986 3,557,609 3,825,599 13,676,358 

Blood & Lymphoid Tissue ...................... 5,369,522 5,760,305 6,136,721 6,476,440 23,742,988 

Endocrine System .................................. 1,016,497 1,068,681 1,117,568 1,140,340 4,343,086 

Soft Tissue Sarcomas ............................ 350,231 371,945 392,408 410,864 1,525,449 

Melanoma .............................................. 597,868 643,798 689,857 721,654 2,653,177 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35601 

33United States Preventive Services Task Force 

(USPSTF) [2008]. Screening for Colorectal Cancer. 

Available at http:// 

www.uspreventiveservicestaskforce.org/uspstf/ 

uspscolo.htm. Accessed May 28, 2012. 

34Mandel JS, et. al, Reducing Mortality From 

Colorectal Cancer by Screening for Fecal Occult 

Blood, NEJM 328(19): 1365–1371 (1993). 

35Subramanian S, et. al. When Budgets Are Tight, 

There Are Better Options Than Colonoscopies For 

Colorectal Cancer Screening. Health Affairs, 

September 2010, 29:9, 1734–1740. 

FECA Rates for FOBT, sigmoidoscopy and 

colonoscopy at non-facility rates: codes 82270, 

45330, and 45378 respectively. 

36FECA rates for Mammography for New York; 

FECA code 77057. 

37U.S. Census Bureau [2011]. Current Population 

Survey. http://www.census.gov/cps/data/. Accessed 

May 26, 2012. 

38Ward E, Halpern M, Schrag N, Cokkinides V, 

DeSantis C, Bandi P, Siegel R, Stewart A, Jemal A 

[2008]. Association of Insurance with Cancer Care 

Utilization and Outcomes. CA Cancer J Clin 58:9– 

31. 

TABLE 8—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE—Continued 

[2011 $] 

Cancer type 2013 2014 2015 2016 2013–2016 

Breast ..................................................... 2,144,624 2,271,916 2,388,445 2,478,716 9,283,702 

Eye/Orbit ................................................ 85,215 92,244 99,165 105,132 381,756 

Total ................................................ 33,026,449 35,642,452 38,181,054 40,646,111 147,496,066 

Summary of Costs and Transfers 

Because HHS lacks data to account for 

either recoupment by health insurance 

or workers’ compensation insurance or 

reduction by Medicare/Medicaid 

payments, the estimates offered here are 

reflective of estimated WTC Health 

Program costs only. This analysis offers 

an assumption about the number of 

individuals who might enroll in the 

WTC Health Program, and estimates the 

impact of a low rate of cancer (U.S. 

population average rate), and an 

increased rate (21 percent greater than 

the U.S. population average) on the 

number of cases and the resulting 

estimated treatment costs to the WTC 

Health Program. This analysis does not 

include administrative costs associated 

with certifying additional diagnoses of 

cancers that are WTC-related health 

conditions that might result from this 

action. Those costs were addressed in 

the interim final rule that established 

regulations for the WTC Health Program 

(76 FR 38914, July 1, 2011). 

Costs and transfers of screening have 

been added to the summary estimates. 

The screening proposed by this 

rulemaking follows U.S. Preventive 

Services Task Force (USPSTF) 

guidelines. 

The USPSTF recommends screening 

for colorectal cancer (cancer of the colon 

and rectum) using fecal occult blood 

testing (FOBT), sigmoidoscopy, or 

colonoscopy, in adults, beginning at age 

50 years and continuing until age 75 

years.33 The costs and transfers include 

the costs of one FOBT for all Program 

enrollees who are over the age of 50 in 

2013, and for those who will reach 50 

years of age in 2014 through 2016. In the 

general population, HHS expects there 

to be 9 percent positive tests. In a 

previous study 34 of those with positive 

tests who were outside the study 

university system, 44 percent had a 

colonoscopy, 42 percent had flexible 

sigmoidoscopy, 11 percent had repeat 

FOBT, and 3 percent were told by their 

physician that no further examination 

was necessary. HHS applied these rates 

to the population and assigned costs for 

each test assuming FOBT cost was 

$7.60, sigmoidoscopy was $238, and a 

colonoscopy was $674.35

The USPSTF recommends breast 

cancer screening using biennial 

mammography for women beginning at 

age 40. HHS assumed that the 

population of responders was 12 

percent female and the population of 

survivors was 50 percent female. Based 

on age distribution information 

available, HHS estimated the number of 

women eligible for screening between 

2013 and 2016. For those screened in 

2013 HHS predicted repeat screening in 

2015 and for those screened in 2014 

HHS predicted repeat screening in 2016. 

The cost of a mammogram was 

estimated at $139.32 based on FECA 

rates for mammography.36

Some responders and survivors 

enrolled or expected to enroll in the 

WTC Health Program already have or 

have access to medical insurance 

coverage by private health insurance, 

employer-provided insurance, 

Medicare, or Medicaid. Therefore, costs 

to the WTC Health Program can be 

divided between societal costs and 

transfer payments. 

To describe these societal costs and 

transfers, the following assumptions 

were used. For the period of coverage 

between January 1, 2013 and December 

31, 2013, HHS has assumed that 16.3 

percent of the survivor population will 

be uninsured, or based on grandfathered 

enrollment of responders, 16,925 are 

covered by the FDNY health plan, while 

39,482 are listed as general responders 

and include construction workers, 

contractors, and others. For this 

analysis, HHS assumed that the nonFDNY general responders and all future 

responder-enrollees are uninsured at the 

same 16.3 percent rate that HHS applied 

to the survivor population, based on 

those without insurance coverage in the 

general U.S. population.37 Ward et al.38

found that access to health care services, 

quality of care received, stage of disease 

at diagnosis, and survival outcomes for 

cancer patients varied according to 

socioeconomic status and demographic 

characteristics. 

Additionally, after the 

implementation of provisions of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148) on January 1, 

2014, all of the enrollees and future 

enrollees can be assumed to have or 

have access to medical insurance 

coverage other than through the WTC 

Health Program. Therefore, all treatment 

costs to be paid by the WTC Health 

Program from 2014 through 2016 are 

considered transfers. 

Table 9 describes the allocation of 

WTC Health Program costs between 

societal costs and transfer payments 

based on 55,000 responders and 5,000 

survivors. Table 10 describes the 

allocation of WTC Health Program costs 

between societal costs and transfer 

payments based on 80,000 responders 

and 30,000 survivors. 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35602 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

TABLE 9—BREAKDOWN OF ESTIMATED ANNUAL WTC HEALTH PROGRAM COSTS AND TRANSFERS, 80,000 & 55,000 

RESPONDERS AND 30,000 AND 5,000 SURVIVORS, 2013–2016, 2011$ 

Societal costs for 2013, 2011$ Annualized transfers for 2013–2016, 

2011$ 

Based on the 16.3 percent of general 

responders and survivors who are 

expected to be uninsured 

Discounted at 7 

percent 

Discounted at 3 

percent 

Cancer rate Cancer rate 

U.S. Average U.S. + 21% U.S. Average U.S. + 21% 

55,000 Responders ................................................................. $1,648,706 .............................. $10,172,308 ..............................

5,000 Survivors ........................................................................ 271,427 .............................. 1,572,907 ..............................

Colorectal and Breast Screening ............................................. 204,491 .............................. 713,321 ..............................

60,000 Total ............................................................................. 2,124,624 .............................. 12,458,535 ..............................

80,000 Responders ................................................................. .............................. $2,631,100 .............................. $19,912,464 

30,000 Survivors ...................................................................... .............................. 1,970,560 .............................. 12,124,118 

Colorectal and Breast Screening ............................................. .............................. 417,521 .............................. 1,271,478 

110,000 Total ........................................................................... .............................. 5,019,182 .............................. 33,308,060 

Examination of Benefits (Health Impact) 

This section describes qualitatively 

the potential benefits of the proposed 

rule in terms of the expected 

improvements in the health and healthrelated quality of life of potential cancer 

patients treated through the WTC Health 

Program, compared to no Program. The 

assessment of the health benefits for 

cancer patients uses the number of 

expected cancer cases that was 

estimated in the cost analysis section. 

HHS does not have information on the 

health of the population that may have 

been exposed to 9/11 agents and is not 

currently enrolled in the WTC Health 

Program. In addition, HHS has only 

limited information about health 

insurance and health care services for 

cancers caused by exposure to 9/11 

agents and suffered by any population 

of responders and survivors, including 

responders and survivors currently 

enrolled in the WTC Health Program 

and responders and survivors not 

enrolled in the Program. For the 

purposes of this analysis, HHS assumes 

that broad trends on demographics and 

access to health insurance reported by 

the U.S. Census Bureau and health care 

services for cancer similar to those 

reported by Ward would apply to the 

population of general responders (those 

individuals who are not members of the 

FDNY and who meet the eligibility 

criteria in 42 CFR Part 88 for WTC 

responders) and survivors both within 

and outside the Program. For the 

purposes of this analysis, HHS assumes 

that access to health insurance and 

health care services for FDNY 

responders within and outside the 

Program would be equivalent because 

this population is overwhelmingly 

covered by employer-based health 

insurance. 

Although HHS cannot quantify the 

benefits associated with the WTC Health 

Program, enrollees with cancer are 

expected to experience a higher quality 

of care than they would in the absence 

of the Program. Mortality and morbidity 

improvements for cancer patients 

expected to enroll in the WTC Health 

Program are anticipated because barriers 

may exist to access and delivery of 

quality health care services for cancer 

patients in the absence of the services 

provided by the WTC Health Program. 

HHS anticipates benefits to cancer 

patients treated through the WTC Health 

Program, who may otherwise not have 

access to health care services (16.3 

percent of general responders and 

survivors who are expected to be 

uninsured), to accrue in 2013. Starting 

in 2014, continued implementation of 

the Affordable Care Act will result in 

increased access to health insurance and 

health care services will improve for the 

general responder and survivor 

population that currently is uninsured. 

HHS is requesting public comment on 

issues relating to access to care, quality 

of care, and the potential benefits 

associated with the WTC Health 

Program. 

Limitations 

The analysis presented here was 

limited by the dearth of verifiable data 

on the cancer status of responders and 

survivors who have yet to apply for 

enrollment in the WTC Health Program. 

Because of the limited data, HHS was 

not able to estimate benefits in terms of 

averted healthcare costs. Nor was HHS 

able to estimate administrative costs, or 

indirect costs, such as averted 

absenteeism, short and long-term 

disability, and productivity losses 

averted due to premature mortality. 

Regulatory Alternatives 

As discussed in section III.D.2., above, 

the Administrator considered 

alternative approaches to the methods 

set forth in this rulemaking. 

One alternative would involve a 

presumption that 9/11 exposures could 

have resulted in the development of any 

and all types of cancer in the exposed 

populations. A presumption that any 

and all types of cancer could occur after 

exposure to 9/11 agents does not require 

any scientific evidence of a positive 

association between exposure and a 

type of cancer. The Administrator 

declined to determine inclusion of types 

of cancer based on a presumption 

approach. The STAC affirmatively 

rejected a recommendation to include 

any and all types of cancer to the List 

of WTC-Related Health Conditions. The 

Administrator made the policy decision 

to include only those types of cancer 

when a positive relationship has been 

established between exposure to the 

9/11 agent and human cancer. 

Another alternative would be to rely 

on epidemiologic studies of the 

association of 9/11 exposures and the 

development of cancer or a type of 

cancer in 9/11-exposed populations 

exclusively. There are several 

limitations to using an exclusive 9/11 

populations study approach. The 

Administrator finds that vast 

uncertainties exist in conducting 

epidemiologic studies of cancer in 9/11- 

exposed populations. For example, 

there exists only very limited, 

individual exposure data in 9/11- 

exposed populations. This lack of 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35603 

39The September 11th Victim Compensation 

Fund of 2001 (VCF) was initially established in 

2001 pursuant to Title IV of Public Law 107–42, 115 

Stat. 230 (Air Transportation Safety and System 

Stabilization Act) and was open for claims from 

December 21, 2001, through December 22, 2003. 

Title II of the Zadroga Act amends and reactivates 

the September 11th Victim Compensation Fund of 

2001. Public Law 111–347. Administered through 

DOJ by a Special Master, the VCF provides 

compensation to any individual (or a personal 

representative of a deceased individual) who 

suffered physical harm or was killed as a result of 

the terrorist-related aircraft crashes of September 

11, 2001, or the debris removal efforts that took 

place in the immediate aftermath of those crashes. 

personal, quantitative exposure data 

impedes the definitive epidemiologic 

evidence that exposure to 9/11 agents 

causes certain types of cancer in 

responder and survivor populations. In 

addition, cancer is generally a long 

latency set of diseases which in some 

cases may take many years or even 

decades to manifest clinically. 

Requiring evidence of positive 

associations from studies of 9/11- 

exposed populations exclusively does 

not serve the best interests of WTC 

Health Program members. 

By expanding the scope of scientific 

information reviewed to include three 

complementary methods (including 

studies in 9/11 exposed populations and 

generally available epidemiologic 

criteria), the Administrator has 

developed a hierarchy of methods to 

guide consideration of whether to 

include types of cancers on the List of 

WTC-Related Health Conditions. 

Effects on Other Agency Programs 

HHS finds that this rulemaking also 

has an effect on the VCF 39 administered 

by DOJ. DOJ administers the VCF under 

rules promulgated at 28 CFR part 104. 

The DOJ regulations define, in 28 CFR 

104.2 (f), the term ‘‘WTC-related health 

condition’’ to mean ‘‘those health 

conditions identified as WTC-related by 

Title I of Public Law 111–347 and by 

regulations implementing that Title.’’ 

The preamble to the VCF final rule (76 

FR 54115) states, ‘‘If the WTC Health 

Program determines that certain forms 

of cancer should be added to the list of 

WTC-related conditions, the final rule 

requires the Special Master to add such 

conditions to the list of presumptively 

covered conditions for the Fund.’’ 

Under the VCF program, 

compensation awards are generally 

calculated using three components: 

Economic loss plus non-economic loss 

minus collateral source payments. To 

determine economic loss, the Special 

Master considers any prior loss of 

earnings or other benefits related to 

employment, medical expense loss, 

replacement services loss, and loss of 

business or employment opportunity. 

The regulations provide presumed noneconomic awards for deceased 

individuals. Because every physical 

injury is unique, the Special Master may 

determine presumed non-economic 

losses on a case-by-case basis for 

physically injured claimants. The 

Special Master then subtracts any 

collateral offsets received or eligible to 

be received. The computation of 

individual compensation due under the 

fund is based on factors pertinent to 

each individual claimant. 

The statute caps the total amount of 

funds allocated to the VCF. The VCF 

regulation at 28 CFR 104.51 provides 

that, ‘‘the total amount of Federal funds 

paid for expenditures including 

compensation with respect to claims 

filed on or after October 3, 2011, will 

not exceed $2,775,000,000. 

Furthermore, the total amount of 

Federal funds expended during the 

period from October 3, 2011, through 

October 3, 2016, may not exceed 

$875,000,000.’’ 

To meet these requirements, the 

Special Master is authorized to reduce 

the amount of compensation due to each 

claimant by prorating the total amount 

of the compensation award determined 

for each individual claimant. The VCF 

intends to establish the fraction for 

proration such that all claimants receive 

some payment related to their claim 

within the overall funding limitation of 

the program. The Special Master may 

adjust the percentage of the total award 

that is to be paid to eligible claims based 

on experiential information as well as 

estimates related to potential future 

claims and availability of funds. 

The amount of compensation that 

would be awarded to each of the living 

claimants who develop, or the heirs of 

those who died from, a covered type of 

cancer during the years 2002 through 

2016, would be determined by 

individual factors considered under the 

VCF. Depending on the total number of 

new claims and compensation 

eligibility, the overall impact on the 

VCF of increasing the number of eligible 

VCF claimants as a result of adding 

eligible health condition under the WTC 

Health Program may be to reduce the 

proration fraction that is applied to all 

VCF claimants such that the total cost 

to the government remains unchanged. 

The additional costs to the VCF due to 

processing and computing the 

entitlement for the extra claimants 

eligible as a result of having a covered 

type of cancer, plus the costs of paying 

newly covered claimants their prorated 

share of the compensation award, would 

result in amounts that will not be 

available to pay increased shares for the 

claimants with non-cancer conditions. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., requires each 

agency to consider the potential impact 

of its regulations on small entities 

including small businesses, small 

governmental units, and small not-forprofit organizations. HHS believes that 

this rule has ‘‘no significant economic 

impact upon a substantial number of 

small entities’’ within the meaning of 

the Regulatory Flexibility Act (5 U.S.C. 

601 et seq.). 

The WTC Health Program has 

contracted with the following healthcare 

providers and provider network 

managers to offer treatment and 

monitoring to enrolled responders and 

survivors: Seven Clinical Centers of 

Excellence (CCE), which serve 

responders and survivors in the New 

York City metropolitan area (City of 

New York Fire Department; Mount Sinai 

School of Medicine; Research 

Foundation of State University of New 

York; New York University, Bellevue 

Hospital Center; University of Medicine 

and Dentistry of New Jersey; Long 

Island Jewish Medical Center; and New 

York City Health and Hospitals 

Corporation); Logistics Health 

Incorporated, which manages the 

nationwide provider network for 

populations geographically distant from 

New York City; three Data Centers, 

which analyze CCE data and coordinate 

activities (City of New York Fire 

Department; Mount Sinai School of 

Medicine; and New York City Health 

and Hospitals Corporation); and 

Emdeon, which manages pharmacy 

benefits. 

Of these entities, six of the seven 

CCEs and two of the three Data Centers 

are hospitals (NAICS 622110—General 

Medical and Surgical Hospitals). The 

Small Business Administration (SBA) 

identifies as a small business those 

hospitals with average annual receipts 

below $34.5 million; none of the six fall 

below the SBA threshold for small 

businesses. The City of New York Fire 

Department’s Bureau of Health Services, 

which provides medical monitoring and 

treatment for FDNY members as a CCE, 

and provides data analysis and other 

services for the FDNY CCE as a Data 

Center, is considered a local government 

agency (NAICS 922160—Fire 

Protection), and as such cannot be 

considered a small entity by SBA. 

Finally, neither Logistics Health 

Incorporated, which manages the 

national provider network, nor Emdeon, 

which manages pharmacy benefits, 

(NAICS 551112—Management of 

Companies and Enterprises) falls below 


erowe on DSK2VPTVN1PROD with PROPOSALS2
35604 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

SBA’s $7 million threshold for small 

businesses in that sector. 

Because no small businesses are 

impacted by this rulemaking, HHS 

certifies that this rule will not have a 

significant economic impact on a 

substantial number of small entities 

within the meaning of the RFA. 

Therefore, a regulatory flexibility 

analysis as provided for under RFA is 

not required. 

C. Paperwork Reduction Act 

The Paperwork Reduction Act (PRA), 

44 U.S.C. 3501 et seq., requires an 

agency to invite public comment on, 

and to obtain OMB approval of, any 

regulation that requires 10 or more 

people to report information to the 

agency or to keep certain records. Data 

collection and recordkeeping 

requirements for the WTC Health 

Program are approved by OMB under 

‘‘World Trade Center Health Program 

Enrollment, Appeals & Reimbursement’’ 

(OMB Control No. 0920–0891, exp. 

December 31, 2014). HHS has 

determined that no changes are needed 

to the information collection request 

already approved by OMB. 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. 801 et 

seq.), HHS will report the promulgation 

of this rule to Congress prior to its 

effective date. 

E. Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1531 et 

seq.) directs agencies to assess the 

effects of Federal regulatory actions on 

State, local, and Tribal governments, 

and the private sector ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this proposed 

rule does not include any Federal 

mandate that may result in increased 

annual expenditures in excess of $100 

million by State, local or Tribal 

governments in the aggregate, or by the 

private sector. However, the rule may 

result in an increase in the contribution 

made by New York City for treatment 

and monitoring, as required by Title 

XXXIII, § 3331(d)(2). For 2012, the 

inflation adjusted threshold is $139 

million. 

F. Executive Order 12988 (Civil Justice) 

This proposed rule has been drafted 

and reviewed in accordance with 

Executive Order 12988, ‘‘Civil Justice 

Reform,’’ and will not unduly burden 

the Federal court system. This rule has 

been reviewed carefully to eliminate 

drafting errors and ambiguities. 

G. Executive Order 13132 (Federalism) 

HHS has reviewed this proposed rule 

in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, HHS has evaluated the 

environmental health and safety effects 

of this proposed rule on children. HHS 

has determined that the rule would have 

no environmental health and safety 

effect on children, although an eligible 

child who has been diagnosed with a 

cancer type specified in this rulemaking 

may seek certification of the condition 

by the Administrator. 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, HHS has evaluated the effects of 

this proposed rule on energy supply, 

distribution or use, and has determined 

that the rule will not have a significant 

adverse effect. 

J. Plain Writing Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS has 

attempted to use plain language in 

promulgating the proposed rule 

consistent with the Federal Plain 

Writing Act guidelines and requests 

comment from the public regarding this 

requirement. 

VI. Proposed Rule 

List of Subjects in 42 CFR Part 88 

Aerodigestive disorders, Appeal 

procedures, Cancer, Health care, Mental 

health conditions, Musculoskeletal 

disorders, Respiratory and pulmonary 

diseases. 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services proposes to amend 42 

CFR part 88 as follows: 

PART 88—WORLD TRADE CENTER 

HEALTH PROGRAM 

1. The authority citation for Part 88 

continues to read as follows: 

Authority: 42 U.S.C. 300mm–300mm–61, 

Pub. L. 111–347, 124 Stat. 3623. 

§ 88.1 [Amended] 

2. Amend § 88.1 by adding paragraph 

(4) to the definition of ‘‘List of WTCrelated health conditions’’ to read as 

follows: 

§ 88.1 Definitions. 

* * * * * 

List of WTC-related health conditions 

* * * 

* * * * * 

(4) Cancers: This list includes those 

individual cancer types specified in 

Table 1, below, according to the 

International Classification of Diseases, 

10th Edition (ICD–10) and International 

Classification of Diseases, 9th Edition 

(ICD–9). 

BILLING CODE P 


erowe on DSK2VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35605 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.009</GPH>
35606 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.010</GPH>
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35607 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.011</GPH>
35608 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.012</GPH>
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35609 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.013</GPH>
35610 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.014</GPH>
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35611 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.015</GPH>
35612 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.016</GPH>
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35613 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.017</GPH>
35614 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.018</GPH>
Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35615 

Dated: May 31, 2012. 

John Howard, 

Administrator, World Trade Center Health 

Program and Director, National Institute for 

Occupational Safety and Health, Centers for 

Disease Control and Prevention, Department 

of Health and Human Services. 

[FR Doc. 2012–14203 Filed 6–8–12; 4:15 pm] 

BILLING CODE C 


erowe on DSK2VPTVN1PROD with PROPOSALS2EP13JN12.019</GPH>